Clinical trial NCT02669433: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Official title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dementia With Lewy Bodies
Keywords: Dementia with Lewy bodies
Lewy bodies
intepirdine
RVT-101
dementia
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 484
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
timeFrame: Change from Baseline at 24 weeks
Secondary outcomes:
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
timeFrame: Change from Baseline at 24 weeks
measure: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
timeFrame: Change from Baseline at 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US138
state: Arizona
city: Phoenix
country: United States
facility: US108
state: Arizona
city: Sun City
country: United States
facility: US139
state: Arizona
city: Tucson
country: United States
facility: US125
state: Arizona
city: Irvine
country: United States
facility: US119
state: California
city: Oxnard
country: United States
facility: US134
state: California
city: Rancho Mirage
country: United States
facility: US133
state: California
city: Sacramento
country: United States
facility: US140
state: California
city: Englewood
country: United States
facility: US141
state: Colorado
city: Washington
country: United States
facility: US123
state: District of Columbia
city: Boca Raton
country: United States
facility: US104
state: Florida
city: Boca Raton
country: United States
facility: US116
state: Florida
city: Jacksonville
country: United States
facility: US111
state: Florida
city: Orlando
country: United States
facility: US122
state: Florida
city: Palm Beach Gardens
country: United States
facility: US137
state: Florida
city: Tampa
country: United States
facility: US126
state: Florida
city: Atlanta
country: United States
facility: US136
state: Georgia
city: Chicago
country: United States
facility: US112
state: Illinois
city: Indianapolis
country: United States
facility: US118
state: Indiana
city: Lexington
country: United States
facility: US105
state: Kentucky
city: Newton
country: United States
facility: US135
state: Massachusetts
city: Quincy
country: United States
facility: US130
state: Massachusetts
city: Rochester
country: United States
facility: US102
state: Minnesota
city: New York
country: United States
facility: US109
state: New York
city: Chapel Hill
country: United States
facility: US100
state: North Carolina
city: Cleveland
country: United States
facility: US110
state: Ohio
city: Columbus
country: United States
facility: US106
state: Ohio
city: Portland
country: United States
facility: US131
state: Oregon
city: Willow Grove
country: United States
facility: US120
state: Pennsylvania
city: Dallas
country: United States
facility: US124
state: Texas
city: Charlottesville
country: United States
facility: US101
state: Virginia
city: Toronto
country: Canada
facility: CA200
state: Ontario
city: Sherbrooke
country: Canada
facility: CA201
state: Quebec
city: Toulouse
country: France
facility: FR952
state: Haute-Garonne
city: Lille
country: France
facility: FR957
state: Nord
city: Villeurbanne
country: France
facility: FR951
state: Rhône
city: Bron
country: France
facility: FR954
city: Paris
country: France
facility: FR959
city: Paris
country: France
facility: FR956
city: Paris
country: France
facility: FR960
city: Saint Herblain
country: France
facility: FR953
city: Strasbourg
country: France
facility: FR950
city: Vandoeuvre les Nancy
country: France
facility: FR955
city: Tricase
country: Italy
facility: IT304
state: Lecce
city: Genova
country: Italy
facility: IT300
state: Liguria
city: Brescia
country: Italy
facility: IT302
state: Lombardia
city: Brescia
country: Italy
facility: IT306
city: Milano
country: Italy
facility: IT301
city: Venice
country: Italy
facility: IT305
city: Amsterdam
country: Netherlands
facility: NE402
state: Noord-Holland
city: Hertogenbosch
country: Netherlands
facility: NE401
city: Rotterdam
country: Netherlands
facility: NE400
city: Barcelona
country: Spain
facility: SP600
city: Barcelona
country: Spain
facility: SP605
city: Burgos
country: Spain
facility: SP602
city: Cambridge
country: United Kingdom
facility: UK801
state: Cambridgeshire
city: Epping
country: United Kingdom
facility: UK808
state: Essex
city: Southampton
country: United Kingdom
facility: UK804
state: Hampshire
city: Bristol
country: United Kingdom
facility: UK807
city: Dundee
country: United Kingdom
facility: UK806
city: Isleworth
country: United Kingdom
facility: UK805
city: London
country: United Kingdom
facility: UK800
city: London
country: United Kingdom
facility: UK809
city: Manchester
country: United Kingdom
facility: UK802
city: Newcastle upon Tyne
country: United Kingdom
facility: UK803
Study officials:
affiliation: Axovant Sciences Inc., Senior Vice President, Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: