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

Phase 2

Completed

Conditions: Dementia With Lewy Bodies

Interventions: Drug: Placebo
Drug: RVT-101 70 mg
Drug: RVT-101 35 mg

Registration Number: NCT02669433

Lead Sponsor: Axovant Sciences Ltd.

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

Status: COMPLETED

Sex: All

Target Recruitment: 484

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
RVT-101 70 mg	RVT-101 70 mg	RVT-101 70 mg once daily
RVT-101 35 mg	RVT-101 35 mg	RVT-101 35 mg once daily

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.

Trial Locations

Locations (65): CA200
🇨🇦
Toronto, Ontario, Canada
US136
🇺🇸
Atlanta, Georgia, United States
US112
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Chicago, Illinois, United States
US133
🇺🇸
Rancho Mirage, California, United States
US116
🇺🇸
Boca Raton, Florida, United States
US110
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Cleveland, Ohio, United States
CA201
🇨🇦
Sherbrooke, Quebec, Canada
UK807
🇬🇧
Bristol, United Kingdom
UK805
🇬🇧
Isleworth, United Kingdom
UK808
🇬🇧
Epping, Essex, United Kingdom
NE400
🇳🇱
Rotterdam, Netherlands
IT300
🇮🇹
Genova, Liguria, Italy
FR951
🇫🇷
Villeurbanne, Rhône, France
UK804
🇬🇧
Southampton, Hampshire, United Kingdom
FR952
🇫🇷
Toulouse, Haute-Garonne, France
UK801
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Cambridge, Cambridgeshire, United Kingdom
IT305
🇮🇹
Venice, Italy
US119
🇺🇸
Irvine, California, United States
US139
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Sun City, Arizona, United States
US125
🇺🇸
Tucson, Arizona, United States
US134
🇺🇸
Oxnard, California, United States
US141
🇺🇸
Englewood, Colorado, United States
US104
🇺🇸
Boca Raton, Florida, United States
US123
🇺🇸
Washington, District of Columbia, United States
US137
🇺🇸
Palm Beach Gardens, Florida, United States
US118
🇺🇸
Indianapolis, Indiana, United States
US111
🇺🇸
Jacksonville, Florida, United States
US130
🇺🇸
Quincy, Massachusetts, United States
US135
🇺🇸
Newton, Massachusetts, United States
US106
🇺🇸
Columbus, Ohio, United States
US120
🇺🇸
Willow Grove, Pennsylvania, United States
US105
🇺🇸
Lexington, Kentucky, United States
US109
🇺🇸
New York, New York, United States
FR957
🇫🇷
Lille, Nord, France
US124
🇺🇸
Dallas, Texas, United States
US101
🇺🇸
Charlottesville, Virginia, United States
FR954
🇫🇷
Bron, France
FR959
🇫🇷
Paris, France
FR956
🇫🇷
Paris, France
FR960
🇫🇷
Paris, France
IT304
🇮🇹
Tricase, Lecce, Italy
FR953
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Saint Herblain, France
FR950
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Strasbourg, France
FR955
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Vandoeuvre les Nancy, France
IT302
🇮🇹
Brescia, Lombardia, Italy
IT306
🇮🇹
Brescia, Italy
IT301
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Milano, Italy
NE402
🇳🇱
Amsterdam, Noord-Holland, Netherlands
NE401
🇳🇱
Hertogenbosch, Netherlands
SP600
🇪🇸
Barcelona, Spain
SP605
🇪🇸
Barcelona, Spain
SP602
🇪🇸
Burgos, Spain
UK809
🇬🇧
London, United Kingdom
UK806
🇬🇧
Dundee, United Kingdom
UK803
🇬🇧
Newcastle upon Tyne, United Kingdom
UK802
🇬🇧
Manchester, United Kingdom
UK800
🇬🇧
London, United Kingdom
US138
🇺🇸
Phoenix, Arizona, United States
US126
🇺🇸
Tampa, Florida, United States
US100
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Chapel Hill, North Carolina, United States
US122
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Orlando, Florida, United States
US108
🇺🇸
Phoenix, Arizona, United States
US140
🇺🇸
Sacramento, California, United States
US131
🇺🇸
Portland, Oregon, United States
US102
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Rochester, Minnesota, United States