Phase 3
Completed N=1,315
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Source: ClinicalTrials.gov NCT02585934 ↗Enrolled (actual)
1,315
Serious AEs
1.8%
Results posted
Dec 2018
Primary outcomePrimary: Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24 — 0.39; 0.75 units on a scale — p=0.2249
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24 |
0.39; 0.75 | 0.2249 |
| PRIMARY Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24 |
-1.06; -0.97 | 0.8260 |
| SECONDARY Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24 |
4.18; 4.30 | 0.0234 sig |
| SECONDARY The Dependence Scale (DS) Score Change From Baseline to Week 24 |
0.30; 0.17 | 0.2096 |
| SECONDARY Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24 |
-0.08; 0.06 | 0.7650 |
| SECONDARY ADAS-Cog-13 Score Change From Baseline to Week 24 |
0.26; 0.64 | 0.2472 |
| SECONDARY Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma |
201.11; 170.95; 198.69; 193.36 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02585934). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.