Alzheimer's Disease MedDRA version: 19.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 100000004852
Conditions
Interventions
Product Name: RVT-101
Product Code: RVT-101
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 607742-69-8
Current Sponsor code: RVT-101
Other descriptive name: 3-Phenylsulfonyl-8-(pipera
Sponsors
Axovant Sciences Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: - Male or female subjects who have completed the last on-treatment visit (V8) of lead-in study RVT-101-3001. - Subject remains on donepezil at the current stable dose for at least the first 4 weeks of this study; changes in donepezil dose and/or use of alternate background therapy during the first 4 weeks may be made only after approval by the Medical Monitor - Female subjects must be: a.Of non-childbearing potential or surgically sterile b.If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening and Baseline Visits. Female subjects of childbearing potential and who are sexually active are required to practice highly effective methods of birth control during the course of the study and until the completion of the follow-up visit. - Male subjects who are sexually active will be required to use an adequate form of birth control including at least 1 barrier method - Subject continues to be able to ingest pills (in tablet form) whole. - Subject has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, subject has provided assent and a legally acceptable representative has provided full written informed consent on behalf of the subject. - Subject is able to comply with the study procedures in the opinion of the Investigator. - General health status is acceptable for participation in this study. -Subject lives with (or has substantial periods of contact with) a regular caregiver who is willing to accompany the subject to every visit, oversee the subject’s compliance with protocol-specified procedures and study medication, and report on subject’s status, and who has substantial contact with the subject. For subjects with a moderate degree of dementia, the caregiver must live with the subject. For subjects with a mild degree of dementia whose caregiver does not cohabitate with them he/she ideally should have a minimum of 10 hours total and at least 3 days contact with the subject per week. Every effort should be made to have the same caregiver throughout the study - Caregiver has provided full written informed consent, on a separate informed consent form, on his/her own behalf prior to the performance of any protocol-specified procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 600
Exclusion criteria
Exclusion criteria: A subject will be excluded from participation in this study if any of the following criteria apply: - Subject experienced an uncontrolled AE in the lead-in study that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. Subjects who experienced an SAE during the lead-in study may be considered for participation in this study only after discussion with the Medical Monitor. - Subject has a clinically significant vital signs or ECG abnormality at the end of the lead-in study, or at the Screening visit for this study, that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. - Subject has a clinically significant laboratory abnormality at V7 or V8 of the lead-in study, or at the Screening visit for this study, that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. Investigators need not wait for V8 results before enrolling the subject in this study. However, any clinically significant abnormality subsequently identified from V8 of the lead-in study and/or at the Screening visit for this study will be evaluated by the Investigator for continued involvement in this study. - Subject has developed any confounding medical or psychiatric condition that would preclude continuation in a 12-month open label extension study, in the opinion of the Investigator. - Significant suicide risk as defined by suicidal ideation as endorsed on items 4 or 5 on the C-SSRS at Screening of this study, or clinical assessment of significant suicidal risk. - Treatment with any concomitant medication detailed in Table 1. - Confirmed corrected QT interval (QTc) value = to 450 msec for males or = 470 msec for females. Subjects with a QRS value greater than 120 msec and QTc value less than 500 msec may be eligible following discussion with the Medical Monitor. - Subject is unable to take the investigational product as prescribed throughout the study (with assistance is acceptable). - Subject or caregiver is an immediate family member or employee of the participating investigator, any of the participating site staff, or of the sponsor study staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of RVT-101 ;Secondary Objective: Not Applicable;Primary end point(s): Incidence of AEs and changes in physical examinations, vital signs measurements, ECGs, clinical laboratory assessments, and C-SSRS results;Timepoint(s) of evaluation of this end point: Week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Croatia, Czech Republic, France, Germany, Italy, Korea, Republic of, Poland, Serbia, Singapore, Slovakia, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactProject Management
Worldwide Clinical Trials
Outcome results
None listed