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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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RVT-101-3001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
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Assessment method [1]
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The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
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Timepoint [1]
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Baseline, 24 weeks
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Primary outcome [2]
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Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24
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Assessment method [2]
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The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function
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Timepoint [2]
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Baseline, 24 weeks
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Secondary outcome [1]
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Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24
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Assessment method [1]
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The CIBIC+ assessment measures the global functioning of the subject. The CIBIC+ is scored as a seven-point categorical rating, ranging from a score of 1 (indicating "very much improved"), to a score of 4 (indicating "no change"), or to a score of 7 (indicating "very much worse.") Lower CIBIC+ scores indicate better (more desirable) function
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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The Dependence Scale (DS) Score Change From Baseline to Week 24
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Assessment method [2]
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The DS measures the amount of assistance patients with dementia require in performing daily activities. The scale consists of 13 items, representing a range of severity from mild to severe levels of dependency. The score range is from 0 to 15 with higher scores indicating greater dependency.
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Timepoint [2]
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Baseline, 24 weeks
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Secondary outcome [3]
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Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24
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Assessment method [3]
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The NPI is a behavior rating scale composed of a 12-item structured interview of the caregiver that is scored from 0 to 144 (the higher the score, the greater the psychiatric disturbance). It assesses 12 behavioral disturbances occurring in dementia patients: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor activity, night-time behavior disturbances, and eating disturbances. Both the frequency and the severity of each behavior are determined.
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Timepoint [3]
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Baseline and Week 24
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Secondary outcome [4]
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ADAS-Cog-13 Score Change From Baseline to Week 24
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Assessment method [4]
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13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.
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Timepoint [4]
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Baseline, 24 weeks
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Secondary outcome [5]
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Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
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Assessment method [5]
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Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24
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Timepoint [5]
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Week 6, Week 12, Week 18, Week 24
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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.
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Minimum age
50
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2017
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Sample size
Target
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Accrual to date
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Final
1315
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Recruitment in Australia
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AU227 - Caulfield
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AU079 - Chermside
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AU032 - Heidelberg West
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AU062 - Herston
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AU138 - West Perth
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VIC3162 - Caulfield
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QLD 4032 - Chermside
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VIC 3081 - Heidelberg West
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QLD 4209 - Herston
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NSW 2077 - Hornsby
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WA 6005 - West Perth
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Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Axovant Sciences Ltd.
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02585934
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Ilise Lombardo, MD
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Axovant Sciences, Inc., Vice President, Clinical Research
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: Protocol
https://cdn.clinicaltrials.gov/large-docs/34/NCT02585934/Prot_000.pdf
Statistical analysis plan
Statistical Analysis Plan: Statistical Analysis Pl...
[
More Details
]
https://cdn.clinicaltrials.gov/large-docs/34/NCT02585934/SAP_001.pdf
Statistical analysis plan
Statistical Analysis Plan: Statistical Analysis Pl...
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https://cdn.clinicaltrials.gov/large-docs/34/NCT02585934/SAP_002.pdf
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