Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, RVT-101, donepezil
Brief summary
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
Detailed description
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
Interventions
DRUGRVT-101 35 mg tablets
once daily, oral tablets
Sponsors
Axovant Sciences Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
* Completed last on-treatment visit of the lead-in study RVT-101-3001
Exclusion criteria
* Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments | Baseline to 12 months or Early Termination | The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments |
Countries
Argentina, Australia, Bulgaria, Canada, Chile, Croatia, Czechia, France, Germany, Italy, Poland, Serbia, Singapore, Slovakia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RVT-101 35 mg Tablets once daily, oral tablets
RVT-101 35 mg tablets: once daily, oral tablets | 1,099 |
| Total | 1,099 |
Baseline characteristics
| Characteristic | RVT-101 35 mg Tablets |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 941 Participants |
| Age, Categorical Between 18 and 65 years | 158 Participants |
| Age, Continuous | 73.1 years STANDARD_DEVIATION 7.55 |
| Body Mass Index (BMI) | 26.59 kg/m^2 STANDARD_DEVIATION 4.653 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 193 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 897 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants |
| Height | 163.3 cm STANDARD_DEVIATION 9.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 44 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) White | 1022 Participants |
| Region of Enrollment Argentina | 103 participants |
| Region of Enrollment Australia | 31 participants |
| Region of Enrollment Bulgaria | 7 participants |
| Region of Enrollment Canada | 37 participants |
| Region of Enrollment Chile | 48 participants |
| Region of Enrollment Croatia | 30 participants |
| Region of Enrollment Czechia | 53 participants |
| Region of Enrollment France | 13 participants |
| Region of Enrollment Germany | 55 participants |
| Region of Enrollment Italy | 61 participants |
| Region of Enrollment Poland | 47 participants |
| Region of Enrollment Serbia | 21 participants |
| Region of Enrollment Singapore | 16 participants |
| Region of Enrollment Slovakia | 42 participants |
| Region of Enrollment South Korea | 9 participants |
| Region of Enrollment Spain | 65 participants |
| Region of Enrollment Taiwan | 16 participants |
| Region of Enrollment United Kingdom | 164 participants |
| Region of Enrollment United States | 281 participants |
| Sex: Female, Male Female | 676 Participants |
| Sex: Female, Male Male | 423 Participants |
| Weight | 71.08 kg STANDARD_DEVIATION 14.49 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 1,099 |
| other Total, other adverse events | 526 / 1,099 |
| serious Total, serious adverse events | 87 / 1,099 |
Outcome results
Primary
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Time frame: Baseline to 12 months or Early Termination
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RVT-101 35 mg Tablets | Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments | Subjects with at least one on-treatment AE | 549 Participants |
| RVT-101 35 mg Tablets | Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments | Subjects with no on-Treatment AE | 550 Participants |