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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/NCT02586909




Registration number
NCT02586909
Ethics application status
Date submitted
23/10/2015
Date registered
27/10/2015
Date last updated
17/04/2020

Titles & IDs
Public title
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
Scientific title
A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
Secondary ID [1] 0 0
RVT-101-3002
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 35 mg tablets

Experimental: RVT-101 35 mg tablets - once daily, oral tablets


Treatment: Drugs: RVT-101 35 mg tablets
once daily, oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
Timepoint [1] 0 0
Baseline to 12 months or Early Termination

Eligibility
Key inclusion criteria
- Completed last on-treatment visit of the lead-in study RVT-101-3001
Minimum age
50 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/03/2018
Sample size
Target
Accrual to date
Final
1099
Recruitment in Australia
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AU227 - Caulfield
Recruitment hospital [2] 0 0
AU032 - Heidelberg West
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AU011 - Hornsby
Recruitment hospital [4] 0 0
AU138 - West Perth
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VIC 3162 - Caulfield
Recruitment postcode(s) [2] 0 0
VIC 3081 - Heidelberg West
Recruitment postcode(s) [3] 0 0
NSW 2077 - Hornsby
Recruitment postcode(s) [4] 0 0
WA 6005 - West Perth
Recruitment outside Australia
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Mendoza
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Ruse
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Sofia
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Zagreb
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Southampton
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Swindon
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Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Axovant Sciences Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02586909
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02586909