protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
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NCT02959138 | 7.1.1 | Adverse Events | 7.1.1. Adverse Events An AE is any untoward medical occurrence in a clinical study subject administered a study drug, which does not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a stu... | [] |
NCT02959138 | 7.1.2 | Serious Adverse Events | 7.1.2. Serious Adverse Events A SAE is defined as an event that, at any dose, results in the following: - Death - Life-threatening (Note: The term "life-threatening" in the definition of "serious" refers to an event in which the subject was at risk of death at the time of the event; it does not refer to an event that h... | [] |
NCT02959138 | 7.1.3 | Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or Serious Adverse Events | 7.1.3. Clinical Laboratory Abnormalities and Other Abnormal Assessments as Adverse Events or Serious Adverse Events Laboratory abnormalities without clinical significance are not recorded as AEs or SAEs. However, laboratory abnormalities (eg, clinical chemistry, hematology, urinalysis) that require medical or surgical ... | [] |
NCT02959138 | 7.2 | Assessment of Adverse Events and Serious Adverse Events | 7.2. Assessment of Adverse Events and Serious Adverse Events The investigator or qualified subinvestigator is responsible for assessing AEs and SAEs for causality and severity, and for final review and confirmation of accuracy of event information and assessments. | [] |
NCT02959138 | 7.2.1 | Assessment of Causality for Study Drugs and Procedures | 7.2.1. Assessment of Causality for Study Drugs and Procedures The investigator or qualified subinvestigator is responsible for assessing the relationship to study drug using clinical judgment and the following considerations: - No: Evidence exists that the AE has an etiology other than the study drug. For SAEs, an alte... | [] |
NCT02959138 | 7.2.2 | Assessment of Severity | 7.2.2. Assessment of Severity The severity grading of AEs will be assessed as Grade 1, 2, 3, 4 or 5 using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. For AEs associated with laboratory abnormalities, the event should be graded on the basis of the clinical severity in the context of the unde... | [] |
NCT02959138 | 7.3 | Investigator Requirements and Instructions for Reporting Adverse Events and Serious Adverse Events to Gilead | 7.3. Investigator Requirements and Instructions for Reporting Adverse Events and Serious Adverse Events to Gilead | [] |
NCT02959138 | 7.3.1 | Requirements for Collection Prior to Study Drug Initiation: | 7.3.1. Requirements for Collection Prior to Study Drug Initiation: After obtaining informed consent, but prior to initiation of study drug, all SAEs and AEs related to protocol-mandated procedures should be reported on the eCRF. | [] |
NCT02959138 | 7.3.1.1 | Adverse Events | 7.3.1.1. Adverse Events Following initiation of study treatment, collect all AEs, regardless of cause or relationship, until 30 days after last administration of study drug must be reported to the eCRF database as instructed. All AEs should be followed up until resolution or until the AE is stable, if possible. Gilead ... | [] |
NCT02959138 | 7.3.1.2 | Serious Adverse Events | 7.3.1.2. Serious Adverse Events All SAEs, regardless of cause or relationship, that occurs after the subject first consents to participate in the study (ie, signing the informed consent) and throughout the duration of the study, including the protocol-required posttreatment follow-up period, must be reported to the eCR... | [] |
NCT02959138 | 7.3.1.3 | Electronic Serious Adverse Event (eSAE) Reporting Process | 7.3.1.3. Electronic Serious Adverse Event (eSAE) Reporting Process - Site personnel record all SAE data in the eCRF database and from there transmit the SAE information to Gilead DSPH within 24 hours of the investigator's knowledge of the event. Detailed instructions may be found in the eCRF completion guidelines. - If... | [] |
NCT02959138 | 7.4 | Gilead Reporting Requirements | 7.4. Gilead Reporting Requirements Depending on relevant local legislation or regulations, including the applicable United States (US) FDA Code of Federal Regulations, the European Union (EU) Clinical Trials Directive (2001/20/EC) and relevant updates, and other country-specific legislation or regulations, Gilead may b... | [] |
NCT02959138 | 7.5 | Toxicity Management | 7.5. Toxicity Management Treatment-emergent toxicities will be noted by the investigator and brought to the attention of the Gilead Sciences medical monitor, who will have a discussion with the investigator and decide the appropriate course of action. Whether or not considered treatment-related, all subjects experienci... | [] |
NCT02959138 | 7.6 | Special Situations Reports | 7.6. Special Situations Reports | [] |
NCT02959138 | 7.6.1 | Definitions of Special Situations | 7.6.1. Definitions of Special Situations Special situation reports include all reports of medication error, abuse, misuse, overdose, occupational exposure with an AE, AE in an infant following exposure from breastfeeding, reports of AEs associated with product complaints, and pregnancy reports regardless of an associat... | [] |
NCT02959138 | 7.6.2 | Instructions for Reporting Special Situations | 7.6.2. Instructions for Reporting Special Situations | [] |
NCT02959138 | 7.6.2.1 | Instructions for Reporting Pregnancies | 7.6.2.1. Instructions for Reporting Pregnancies The investigator should report pregnancies in female study subjects that are identified after initiation of study drug and throughout the study, including the poststudy drug follow-up period, to Gilead DSPH using the pregnancy report form within 24 hours of becoming aware... | [] |
NCT02959138 | 7.6.2.2 | Reporting Other Special Situations | 7.6.2.2. Reporting Other Special Situations All other special situation reports must be reported on the special situations report form and forwarded to Gilead DSPHwithin 24 hours of the investigator becoming aware of the situation. These reports must consist of situations that involve study drug and/or Gilead concomita... | [] |
NCT02959138 | 8 | STATISTICAL CONSIDERATIONS | 8. STATISTICAL CONSIDERATIONS | [] |
NCT02959138 | 8.1 | Analysis Objectives and Endpoints | 8.1. Analysis Objectives and Endpoints | [] |
NCT02959138 | 8.1.1 | Analysis Objectives | 8.1.1. Analysis Objectives The primary objective of this study is as follows: To evaluate the PK of GS-9876 in subjects with impaired renal function relative to matched, healthy controls The secondary objective of this study is as follows: To evaluate the safety and tolerability of GS-9876 in subjects with normal and i... | [] |
NCT02959138 | 8.1.2 | Primary Endpoint | 8.1.2. Primary Endpoint The primary endpoints are PK parameters AUClast, AUCinf, and Cmax for GS-9876. | [] |
NCT02959138 | 8.1.3 | Secondary Endpoint | 8.1.3. Secondary Endpoint The secondary endpoints include incidences of AEs, laboratory abnormalities, abnormal findings in vital signs and safety ECG monitoring. | [] |
NCT02959138 | 8.2 | Analysis Conventions | 8.2. Analysis Conventions | [] |
NCT02959138 | 8.2.1 | Analysis Sets | 8.2.1. Analysis Sets | [] |
NCT02959138 | 8.2.1.1 | All Enrolled | 8.2.1.1. All Enrolled The All Enrolled Analysis Set includes all subjects enrolled into the study after screening. This is primary analysis set for listings. | [] |
NCT02959138 | 8.2.1.2 | Safety | 8.2.1.2. Safety The Safety Analysis Set will include all enrolled subjects who received 1 dose of GS-9876. | [] |
NCT02959138 | 8.2.1.3 | Pharmacokinetics | 8.2.1.3. Pharmacokinetics The PK Analysis Set will include all enrolled subjects who received 1 dose of GS-9876 and had at least 1 nonmissing PK concentration datum reported by PK lab. | [] |
NCT02959138 | 8.3 | Data Handling Conventions | 8.3. Data Handling Conventions For summary statistics, PK concentration values below the limit of quantitation (BLQ) will be treated as zero at predose and 1-half of the lower limit of quantitation (LLOQ) for postdose time points. Laboratory data that are continuous in nature but are less than the LLOQ or above the upp... | [] |
NCT02959138 | 8.4 | Demographic Data and Baseline Characteristics | 8.4. Demographic Data and Baseline Characteristics Demographic and baseline measurements will be summarized and descriptive statistics will be provided. Demographic summaries will include sex, race/ethnicity, enrollment, and age. | [] |
NCT02959138 | 8.5 | Interim Analysis | 8.5. Interim Analysis Review of available safety and PK data will be conducted by the sponsor to facilitate the decision of enrolling adaptive cohorts. | [] |
NCT02959138 | 8.6 | Safety Analysis | 8.6. Safety Analysis All safety data collected on or after the date that study drug was first administered up to the date of last dose of study drug plus 30 days will be summarized by renal function group using Safety Analysis Set. | [] |
NCT02959138 | 8.6.1 | Extent of Exposure | 8.6.1. Extent of Exposure A subject's extent of exposure to study drug data will be generated from the study drug administration page in eCRF. Exposure data will be listed. | [] |
NCT02959138 | 8.6.2 | Adverse Events | 8.6.2. Adverse Events Clinical and laboratory AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be attached to the clinical database. Adverse event data wi... | [] |
NCT02959138 | 8.6.3 | Laboratory Evaluations | 8.6.3. Laboratory Evaluations Listings of individual subject laboratory results will be provided. Laboratory results and change from predose values for selected lab tests will be summarized by renal function group at scheduled visits. The incidence of treatment-emergent graded laboratory abnormalities will be summarize... | [] |
NCT02959138 | 8.6.4 | Other Safety Evaluations | 8.6.4. Other Safety Evaluations Vital signs and ECG data will be summarized by renal function group. | [] |
NCT02959138 | 8.7 | Pharmacokinetic Analysis | 8.7. Pharmacokinetic Analysis Plasma concentrations and PK parameters for GS-9876 will be listed and summarized by renal function group using descriptive statistics (eg, sample size, mean, SD, % coefficient of variation, median, first quartile [Q1], third quartile [Q3], minimum, and maximum). In addition, an analysis o... | [] |
NCT02959138 | 8.8 | Sample Size | 8.8. Sample Size With 16 (8 per group) evaluable subjects, the estimated two-sided 90% CI of the GLSM ratio of test versus reference groups, with regards to PK parameters (AUC and Cmax) would be within (50%, 200%) with over 95% probability. This calculation is based on a two group t-test of equivalence in means at the ... | [] |
NCT02959138 | 9 | RESPONSIBILITIES | 9. RESPONSIBILITIES | [] |
NCT02959138 | 9.1 | Investigator Responsibilities | 9.1. Investigator Responsibilities | [] |
NCT02959138 | 9.1.1 | Good Clinical Practice | 9.1.1. Good Clinical Practice The investigator will ensure that this study is conducted in accordance with the principles of the Declaration of Helsinki (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International Conference on Harmonization (ICH) guidelines, or with the laws and regulations of ... | [] |
NCT02959138 | 9.1.2 | Institutional Review Board/Independent Ethics Committee Review and Approval | 9.1.2. Institutional Review Board/Independent Ethics Committee Review and Approval The investigator (or sponsor as appropriate according to local regulations) will submit this protocol, ICF, and any accompanying material to be provided to the subject (such as advertisements, subject information sheets, or descriptions ... | [] |
NCT02959138 | 9.1.3 | Informed Consent | 9.1.3. Informed Consent The investigator is responsible for obtaining written informed consent from each individual participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of the study and before undertaking any study-related procedures. The investigator must use t... | [] |
NCT02959138 | 9.1.4 | Confidentiality | 9.1.4. Confidentiality The investigator must assure that subjects' anonymity will be strictly maintained and that their identities are protected from unauthorized parties. Only subject initials, date of birth, another unique identifier (as allowed by local law), and an identification code will be recorded on any form o... | [] |
NCT02959138 | 9.1.5 | Study Files and Retention of Records | 9.1.5. Study Files and Retention of Records The investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into at least the following 2 categories: (1) investigator's study file ... | [] |
NCT02959138 | 9.1.6 | Case Report Forms | 9.1.6. Case Report Forms For each subject enrolled, an eCRF will be completed by an authorized study staff member whose training for this function is documented according to study procedures. The eCRF should be completed on the day of the subject visit to enable the sponsor to perform central monitoring of safety data,... | [] |
NCT02959138 | 9.1.7 | Study Drug Accountability and Return | 9.1.7. Study Drug Accountability and Return Where possible, IMP should be destroyed at the site. At the start of the study, the study monitor will evaluate each study center's IMP disposal procedures and provide appropriate instruction for disposal or return of unused IMP supplies. If the site has an appropriate standa... | [] |
NCT02959138 | 9.1.8 | Inspections | 9.1.8. Inspections The investigator will make available all source documents and other records for this study to Gilead's appointed study monitors, to IRB/EC, or to regulatory authority or health authority inspectors. | [] |
NCT02959138 | 9.1.9 | Protocol Compliance | 9.1.9. Protocol Compliance The investigator is responsible for ensuring the study is conducted in accordance with the procedures and evaluations described in this protocol. | [] |
NCT02959138 | 9.2 | Sponsor Responsibilities | 9.2. Sponsor Responsibilities | [] |
NCT02959138 | 9.2.1 | Protocol Modifications | 9.2.1. Protocol Modifications Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only by Gilead. The investigator must submit all protocol modifications to IRB/EC in accordance with local requirements and receive documented IRB/EC approval before modifications may be i... | [] |
NCT02959138 | 9.2.2 | Study Report and Publications | 9.2.2. Study Report and Publications A clinical study report will be prepared and provided to the regulatory agency(ies). Gilead will ensure that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study Reports (ICH E3). Note that an abbreviated report may be prepared in c... | [] |
NCT02959138 | 9.3 | Joint Investigator/Sponsor Responsibilities | 9.3. Joint Investigator/Sponsor Responsibilities | [] |
NCT02959138 | 9.3.1 | Payment Reporting | 9.3.1. Payment Reporting Investigators and their study staff may be asked to provide services performed under this protocol, eg, attendance at investigator's meetings. If required under the applicable statutory and regulatory requirements, Gilead will capture and disclose to federal and state agencies any expenses paid... | [] |
NCT02959138 | 9.3.2 | Access to Information for Monitoring | 9.3.2. Access to Information for Monitoring In accordance with regulations and guidelines, the study monitor must have direct access to the investigator's source documentation in order to verify the accuracy of the data recorded in the eCRF. The monitor is responsible for routine review of the eCRF at regular intervals... | [] |
NCT02959138 | 9.3.3 | Access to Information for Auditing or Inspections | 9.3.3. Access to Information for Auditing or Inspections Representatives of regulatory authorities or of Gilead may conduct inspections or audits of the clinical study. If the investigator is notified of an inspection by a regulatory authority the investigator agrees to notify the Gilead medical monitor immediately. Th... | [] |
NCT02959138 | 9.3.4 | Study Discontinuation | 9.3.4. Study Discontinuation Both Gilead and the investigator reserve the right to terminate the study at any time. Should this be necessary, both parties will arrange discontinuation procedures and notify the subjects, appropriate regulatory authority(ies), IRBs, and ECs. In terminating the study, Gilead and the inves... | [] |
NCT02959138 | 10 | REFERENCES | 10. REFERENCES Arthritis Foundation. Rheumatoid Arthritis Fact Sheet. 2008. - Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41. - Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, et al. Estimates of the prevalence of arthritis and other rheumatic c... | [] |
NCT02959138 | 11 | APPENDICES | 11. APPENDICES | Appendix 1. | Investigator Signature Page | |-------------|------------------------------------------------------| | Appendix 2. | Management of Clinical and Laboratory Adverse Events | Appendix 3. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive Requirements Ap... | [
"GILEAD SCIENCES, INC. 333 LAKESIDE DRIVE FOSTER CITY, CA 94404",
"STUDY ACKNOWLEDGEMENT",
"Appendix 2. Management of Clinical and Laboratory Adverse Events",
"Appendix 3. Pregnancy Precautions, Definition for Female of Childbearing Potential, and Contraceptive Requirements",
"1) Definitions",
"a) Definit... |
NCT02972658 | 1 | Synopsis | 1. Synopsis
Title of Study: A Randomized, Double-Blind, Delayed-Start Study of LY3314814 in Early Alzheimer's Disease Dementia (extension of Study AZES).
Rationale: LY3314814 is being developed for the modification of the clinical course of Alzheimer's disease (AD) by slowing disease progression in patients diagnosed... | [
"Title of Study:",
"Rationale:",
"Objective(s)/Endpoints:",
"Summary of Study Design:",
"Treatment Arms and Duration:",
"Number of Patients:",
"Statistical Analysis:"
] |
NCT02972658 | 2 | Schedule of Activities | 2. Schedule of Activities | Study procedurea | | Delayed-StartYear 1 | | | | | | | Delayed-Start Year 2 | EDb | F/U | | | | | | | |---------------------------------------------------------|-----------------------|-------------------------|--------|----|----|----|--------|-----|----------------------|-----|--------|----... | [] |
NCT02972658 | 3 | Introduction | 3. Introduction | [] |
NCT02972658 | 3.1 | Study Rationale | 3.1. Study Rationale Eli Lilly and Company (Lilly) and AstraZeneca (AZ) have entered into an alliance to develop LY3314814 (AZD3293). Throughout this document, only the Lilly compound identifier (LY3314814) will be used since Lilly is designated as the sponsor. In addition, the Study code I8D-MC-AZFD/D5010C00030 will b... | [] |
NCT02972658 | 3.2 | Background | 3.2. Background Alzheimer's disease is a progressive and fatal neurodegenerative disease manifested by cognitive deterioration in addition to progressive impairment of activities of daily living. Current treatments are seen as minimally effective, with only minor symptomatic improvements for a limited duration, and the... | [] |
NCT02972658 | 3.3 | Benefit/Risk Assessment | 3.3. Benefit/Risk Assessment To date, no safety issues have been identified that would create an unfavorable benefit-risk balance for LY3314814. The potential benefits are not established but expectation for an effect in slowing AD progression is described above in Section [3.2.](#page-13-0) Potential risks include but... | [] |
NCT02972658 | 4 | Objectives and Endpoints | 4. Objectives and Endpoints [Table](#page-15-1) 4.1 shows the objectives and endpoints of the study. Table 4.1. Objectives and Endpoints | Objectives | Endpoints | |-----------------------------------------------------------------------------------------------------------------------------------------------------------... | [] |
NCT02972658 | 5 | Study Design | 5. Study Design | [] |
NCT02972658 | 5.1 | Overall Design | 5.1. Overall Design Study AZFD is a multicenter, randomized, parallel-group, double-blind, 104-week-long study of 2 fixed dose levels of LY3314814 in patients with early AD at the time of enrollment into the feeder Study AZES. The actual number of patients to be enrolled is dependent on the number of eligible patients ... | [] |
NCT02972658 | 5.2 | Number of Participants | 5.2. Number of Participants It is estimated that approximately 1540 participants will complete the feeder Study AZES. Based on historical data, it is assumed that 90% (approximately 1400) of the participants from Study AZES will provide consent to continue participation in Study AZFD. Consent for Study AZFD may be obta... | [] |
NCT02972658 | 5.3 | End of Study Definition | 5.3. End of Study Definition The end of the study is defined as "the last visit of the last patient undergoing the study." This definition applies to the entire study and is not region specific. The study is expected to start in Q1 of 2017 which is the scheduled date for the first completers of the feeder Study AZES. T... | [] |
NCT02972658 | 5.4 | Scientific Rationale for Study Design | 5.4. Scientific Rationale for Study Design Study AZFD integrated with Study AZES forms a Delayed Start study design. Data from randomization (Visit 2) in Study AZES through Visit 7 of Study AZFD will be used to test whether there is a treatment effect that cannot be achieved with a later start of treatment. The time po... | [] |
NCT02972658 | 5.5 | Justification for Dose | 5.5. Justification for Dose LY3314814 is administered orally at doses of 20 and 50 mg daily and the doses were selected based on preclinical and pharmacodynamic (PD) data. The projected therapeutic dose range is based on levels of inhibition of BACE1 in the central nervous system as calculated from the multiple-ascendi... | [] |
NCT02972658 | 6 | Study Population | 6. Study Population Eligible patients will be men and women completing feeder Study AZES. Eligible patients must have been randomized into Study AZES, and completed the primary protocol through Visit 20 without permanent discontinuation of study treatment. Prospective approval of protocol deviations to recruitment and ... | [] |
NCT02972658 | 6.1 | Inclusion Criteria | 6.1. Inclusion Criteria
General Inclusion Criteria - [1] Provision of signed, written and dated informed consent from patient (or legal representative if required) and from study partner prior to any study specific procedures being performed. - [2] Patients participating through Visit 20 of Study AZES and who have not... | [
"General Inclusion Criteria"
] |
NCT02972658 | 6.2 | Exclusion Criteria | 6.2. Exclusion Criteria
General Exclusion Criteria - [6] Patients should not have participated or currently participate in any other clinical trial or any other type of medical research judged not to be scientifically or medically compatible with this study for the duration of their participation in the current study.... | [
"General Exclusion Criteria"
] |
NCT02972658 | 6.3 | Lifestyle Restrictions | 6.3. Lifestyle Restrictions Patients will be required to: - 1. Refrain from donating blood from the Visit 1 until 3 months after the follow-up visit. - 2. Follow restrictions regarding concomitant medications according to Section [7.7.](#page-25-2) - 3. Avoid use of tanning beds and self-tanning products. - 4. Wear a h... | [] |
NCT02972658 | 6.4 | Screen Failures | 6.4. Screen Failures Patients who do not meet the criteria for participation in this study (screen failure) may not be rescreened. | [] |
NCT02972658 | 6.5 | Study Partner | 6.5. Study Partner Every patient in the study must have a study partner, who must sign an informed consent form (ICF). An identification number will be assigned to each study partner and recorded for each efficacy measure that the study partner provides input. The study partner should be willing to participate in every... | [] |
NCT02972658 | 7 | Treatments | 7. Treatments | [] |
NCT02972658 | 7.1 | Treatments Administered | 7.1. Treatments Administered LY3314814 film-coated tablets in two different strengths (20 and 50 mg) and matching placebo will be manufactured and provided by AZ. Investigational product will be dispensed as outlined in the Schedule of Activities (Section [2\)](#page-10-0). Since the LY3314814 20 mg tablets and the LY3... | [] |
NCT02972658 | 7.1.1 | Packaging and Labeling | 7.1.1. Packaging and Labeling All study medication will be provided in child resistant blister packs. The blister packs will be further packaged into patient compliance kits. Each kit will have a unique kit number. Enough tablets will be dispensed for daily dosing until the patient returns for the next study visit. Sub... | [] |
NCT02972658 | 7.2 | Method of Treatment Assignment | 7.2. Method of Treatment Assignment Patients who meet all criteria for enrollment will be randomized as the last procedure of Visit 1 of Study AZFD (Visit 20 of Study AZES). Assignment to treatment groups will be determined by a computer-generated random sequence using an interactive web- and voice-response system (IxR... | [] |
NCT02972658 | 7.2.1 | Selection and Timing of Doses | 7.2.1. Selection and Timing of Doses Patients will continue on Study AZES study treatment during the entire period of Visit 20 of Study AZES. To ensure that patients continue on study treatment without a lapse in therapy, patients will take their last dose of Study AZES treatment on the day of randomization into Study ... | [] |
NCT02972658 | 7.3 | Blinding | 7.3. Blinding This is a double-blind study. Both patients and site personnel will remain blind to dose throughout the study. Emergency unblinding for AEs may be performed through the IxRS, which may supplement or take the place of emergency codes generated by a computer drug-labeling system. This option may be used ONL... | [] |
NCT02972658 | 7.4 | Dosage Modification | 7.4. Dosage Modification Dose adjustments are not permitted in this study. | [] |
NCT02972658 | 7.5 | Preparation/Handling/Storage/Accountability | 7.5. Preparation/Handling/Storage/Accountability All study medication must be kept in a secure place under appropriate storage conditions. Appropriate storage conditions are specified on the study medication label. The study medication provided for this study will only be used as directed in the study protocol. The stu... | [] |
NCT02972658 | 7.6 | Treatment Compliance | 7.6. Treatment Compliance Patient compliance with study medication will be assessed at each visit by direct questioning and counting returned tablets. The patient should be instructed to retain all empty drug packages after using up the medication in the package and to bring the empty packages and any unused medication... | [] |
NCT02972658 | 7.7 | Concomitant Therapy | 7.7. Concomitant Therapy Concomitant medications with the potential to affect cognition are permitted. These include, but are not limited to, cholinesterase inhibitors, opiates, ginkgo biloba and other approved nootropics, anxiolytics, antidepressants, sedative-hypnotics, hormone replacement therapy, sleeping aids, sed... | [] |
NCT02972658 | 7.7.1 | Initiation of Post-Randomization Symptomatic AD Treatments | 7.7.1. Initiation of Post-Randomization Symptomatic AD Treatments Over the period of this trial patients may have progression of symptoms/disease (patients may progress to mild or moderate/severe stages of disease). For patients for whom treatment becomes medically indicated during the trial, initiation of cholinestera... | [] |
NCT02972658 | 7.7.2 | Other Medication Considerations Post-Randomization | 7.7.2. Other Medication Considerations Post-Randomization Permitted concomitant medications should be maintained on a stable dose regimen during the study whenever possible. Attempts should be made to maintain stable doses of symptomatic AD medication, however, changes or additions are permitted when clinically indicat... | [] |
NCT02972658 | 7.8 | Treatment after the End of the Study | 7.8. Treatment after the End of the Study | [] |
NCT02972658 | 7.8.1 | Study Extensions | 7.8.1. Study Extensions There is not currently a plan to extend the study beyond the Follow-up Visit (Visit 801). | [] |
NCT02972658 | 7.8.2 | Continued Access | 7.8.2. Continued Access Continued access would only be provided through a regulatory and IRB-approved protocol, where applicable. Safety and efficacy data may be collected during this time period. | [] |
NCT02972658 | 8 | Discontinuation Criteria | 8. Discontinuation Criteria | [] |
NCT02972658 | 8.1 | Discontinuation from Study Treatment | 8.1. Discontinuation from Study Treatment | [] |
NCT02972658 | 8.1.1 | Discontinuation from Study Treatment | 8.1.1. Discontinuation from Study Treatment Discontinuation of the investigational product for abnormal liver tests should be considered by the investigator when a patient meets one of the following conditions after consultation with the Sponsor-designated medical monitor: - Alanine aminotransferase (ALT) or aspartate ... | [] |
NCT02972658 | 8.1.2 | Temporary Discontinuation from Study Treatment | 8.1.2. Temporary Discontinuation from Study Treatment Treatment suspension and re-dosing of study drug can be considered based on the Principal Investigator's judgment (examples include short-term treatment using a prohibited drug, uncertain adverse event, hospitalization). The maximum cumulative permissible treatment ... | [] |
NCT02972658 | 8.1.3 | Discontinuation of Inadvertently Enrolled Patients | 8.1.3. Discontinuation of Inadvertently Enrolled Patients If the Sponsor or investigator identifies a patient who did not meet enrollment criteria and was inadvertently enrolled, a discussion must occur between the Sponsor-designated medical monitor and the investigator to determine if the patient may continue in the s... | [] |
NCT02972658 | 8.2 | Discontinuation from the Study | 8.2. Discontinuation from the Study Some possible reasons that may lead to permanent discontinuation include: - Enrollment in any other clinical trial involving an investigational product or enrollment in any other type of medical research judged not to be scientifically or medically compatible with this study. - Parti... | [] |
NCT02972658 | 8.3 | Lost to Follow-Up | 8.3. Lost to Follow-Up A patient will be considered lost to follow-up if he or she fails to return for scheduled visits and is unable to be contacted by the study site. Site personnel are expected to make diligent attempts to contact patients who fail to return for a scheduled visit or were otherwise unable to be follo... | [] |
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