Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

Phase 2

Completed

Brief Summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

Detailed Description: The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.

The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).

Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Recruitment & Eligibility

Inclusion Criteria

Male or female subject with probable DLB
Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
Patients currently receiving therapy for DLB are eligible for enrollment

Exclusion Criteria

Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24	Change from Baseline at 24 weeks	The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.

Secondary Outcome Measures

Name	Time	Method
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24	Change from Baseline at 24 weeks	To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24	Change from Baseline at 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.

Locations (65): US138
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Phoenix, Arizona, United States
US108
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Phoenix, Arizona, United States
US139
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Sun City, Arizona, United States
US125
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Tucson, Arizona, United States
US119
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Irvine, California, United States
US134
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Oxnard, California, United States
US133
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Rancho Mirage, California, United States
US140
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Sacramento, California, United States
US141
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Englewood, Colorado, United States
US123
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Washington, District of Columbia, United States
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US138
🇺🇸Phoenix, Arizona, United States