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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02585934




Registration number
NCT02585934
Ethics application status
Date submitted
22/10/2015
Date registered
26/10/2015
Date last updated
5/12/2018

Titles & IDs
Public title
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Scientific title
A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease
Secondary ID [1] 0 0
RVT-101-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RVT-101
Treatment: Drugs - Placebo

Experimental: RVT-101 - RVT-101 adjunct to 5 mg or 10 mg donepezil

Placebo Comparator: Placebo - Placebo adjunct to 5 mg or 10 mg donepezil


Treatment: Drugs: RVT-101
once daily, oral, 35 mg tablets

Treatment: Drugs: Placebo
once daily, oral, pill manufactured to match RVT-101 35 mg tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
Timepoint [1] 0 0
Baseline, 24 weeks
Primary outcome [2] 0 0
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24
Timepoint [2] 0 0
Baseline, 24 weeks
Secondary outcome [1] 0 0
Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
The Dependence Scale (DS) Score Change From Baseline to Week 24
Timepoint [2] 0 0
Baseline, 24 weeks
Secondary outcome [3] 0 0
Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
ADAS-Cog-13 Score Change From Baseline to Week 24
Timepoint [4] 0 0
Baseline, 24 weeks
Secondary outcome [5] 0 0
Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
Timepoint [5] 0 0
Week 6, Week 12, Week 18, Week 24

Eligibility
Key inclusion criteria
- Male or female subject with AD

- Ongoing donepezil therapy for AD

- An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline

- Hachinski Ischaemia score less than or equal to 4 at Screening.

- If female, subject must be: a. of non-childbearing potential or surgically sterile;
or, b. willing to use an adequate methods of birth control. Male subjects who are
sexually active will also be required to use an adequate form of birth control.

- Subject has the ability to comply with procedures for cognitive and other testing in
the opinion of the investigator.

- Subject has a reliable caregiver who is willing to report on subject's status
throughout the study.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other Causes for Dementia

- Diagnosis of vascular dementia

- Atypical clinical features or clinical course of dementia that would lead the
investigator to conclude symptoms are more likely due to an alternate dementia
diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia,
or others.

Confounding Medical Conditions

- History of significant psychiatric illness such as schizophrenia or bipolar affective
disorder or any other significant psychiatric illness that in the opinion of the
investigator would interfere with participation in the study;

- Any clinically relevant concomitant disease, which, in the opinion of the
investigator, makes the subject unsuitable for inclusion in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
Accrual to date
Final
1315
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU227 - Caulfield
Recruitment hospital [2] 0 0
AU079 - Chermside
Recruitment hospital [3] 0 0
AU032 - Heidelberg West
Recruitment hospital [4] 0 0
AU062 - Herston
Recruitment hospital [5] 0 0
AU011 - Hornsby
Recruitment hospital [6] 0 0
AU138 - West Perth
Recruitment postcode(s) [1] 0 0
VIC3162 - Caulfield
Recruitment postcode(s) [2] 0 0
QLD 4032 - Chermside
Recruitment postcode(s) [3] 0 0
VIC 3081 - Heidelberg West
Recruitment postcode(s) [4] 0 0
QLD 4209 - Herston
Recruitment postcode(s) [5] 0 0
NSW 2077 - Hornsby
Recruitment postcode(s) [6] 0 0
WA 6005 - West Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Axovant Sciences Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an
adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02585934
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ilise Lombardo, MD
Address 0 0
Axovant Sciences, Inc., Vice President, Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/ct2/show/NCT02585934