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Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

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ClinicalTrials.gov Identifier: NCT02585934
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.

Tracking Information
First Submitted Date  ICMJE October 22, 2015
First Posted Date  ICMJE October 26, 2015
Results First Submitted Date  ICMJE September 30, 2018
Results First Posted Date  ICMJE December 5, 2018
Last Update Posted Date December 5, 2018
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    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.
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • Change from baseline on Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 items (ADAS-Cog-11) [ Time Frame: 24 weeks ]
  • Change from baseline on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT02585934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2018)
  • Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24 [ Time Frame: 24 weeks ]
    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
  • The Dependence Scale (DS) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    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.
  • Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
    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.
  • ADAS-Cog-13 Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    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.
  • Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma [ Time Frame: Week 6, Week 12, Week 18, Week 24 ]
    Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2015)
  • Clinical Global Impression of Change - plus carer interview (CIBIC+) [ Time Frame: 24 weeks ]
  • Change in Neuropsychiatric Inventory (NPI) total score [ Time Frame: Baseline and Week 24 ]
  • Change in EQ-5D Visual Analogue Scale (EQ-5D-VAS) [ Time Frame: Baseline and 24 weeks ]
  • Occurrence of all reported adverse events (AEs) and events noted by investigators on clinical examination, electrocardiograms (ECGs), routine laboratory assessments [ Time Frame: Baseline to 24 weeks or Early Termination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Official Title  ICMJE 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
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.
Detailed Description This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: RVT-101
    once daily, oral, 35 mg tablets
  • Drug: Placebo
    once daily, oral, pill manufactured to match RVT-101 35 mg tablet
Study Arms  ICMJE
  • Experimental: RVT-101
    RVT-101 adjunct to 5 mg or 10 mg donepezil
    Intervention: Drug: RVT-101
  • Placebo Comparator: Placebo
    Placebo adjunct to 5 mg or 10 mg donepezil
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2017)
1315
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2015)
1150
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Canada,   Chile,   Croatia,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02585934
Other Study ID Numbers  ICMJE RVT-101-3001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Axovant Sciences Ltd.
Study Sponsor  ICMJE Axovant Sciences Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Vice President, Clinical Research
PRS Account Axovant Sciences Ltd.
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP