Clinical trial NCT02585934: Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
RVT-101
donepezil
intepirdine
dementia
Lead sponsor: Sio Gene Therapies
Sponsor class: INDUSTRY
First posted: 2015-10-26
Enrollment: 1315
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 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.

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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24
timeFrame: 24 weeks
measure: The Dependence Scale (DS) Score Change From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: ADAS-Cog-13 Score Change From Baseline to Week 24
timeFrame: Baseline, 24 weeks
measure: Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma
timeFrame: Week 6, Week 12, Week 18, Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: US112
state: Arizona
city: Tucson
country: United States
facility: US220
state: Arizona
city: Encino
country: United States
facility: US168
state: California
city: Fullerton
country: United States
facility: US117
state: California
city: Los Angeles
country: United States
facility: US214
state: California
city: Pasadena
country: United States
facility: US189
state: California
city: Rancho Mirage
country: United States
facility: US096
state: California
city: Santa Ana
country: United States
facility: US0195
state: California
city: Simi Valley
country: United States
facility: US016
state: California
city: Temecula
country: United States
facility: US106
state: California
city: Hamden
country: United States
facility: US179
state: Connecticut
city: Norwich
country: United States
facility: US171
state: Connecticut
city: Atlantis
country: United States
facility: US088
state: Florida
city: Brooksville
country: United States
facility: US007
state: Florida
city: Hallandale Beach
country: United States
facility: US002
state: Florida
city: Hialeah
country: United States
facility: US140
state: Florida
city: Miami
country: United States
facility: US216
state: Florida
city: Miami
country: United States
facility: US110
state: Florida
city: North Palm Beach
country: United States
facility: US172
state: Florida
city: Orlando
country: United States
facility: US003
state: Florida
city: Pensacola
country: United States
facility: US256
state: Florida
city: Tampa
country: United States
facility: US037
state: Florida
city: Tampa
country: United States
facility: US042
state: Florida
city: The Villages
country: United States
facility: US004
state: Florida
city: Atlanta
country: United States
facility: US048
state: Georgia
city: Atlanta
country: United States
facility: US046
state: Georgia
city: Columbus
country: United States
facility: US217
state: Georgia
city: Baton Rouge
country: United States
facility: US111
state: Louisiana
city: Shreveport
country: United States
facility: US095
state: Louisiana
city: Newton
country: United States
facility: US116
state: Massachusetts
city: Quincy
country: United States
facility: US174
state: Massachusetts
city: Hattiesburg
country: United States
facility: US144
state: Mississippi
city: Las Vegas
country: United States
facility: US094
state: Nevada
city: Berlin
country: United States
facility: US135
state: New Jersey
city: Lawrenceville
country: United States
facility: US197
state: New Jersey
city: Manchester
country: United States
facility: US057
state: New Jersey
city: Mount Arlington
country: United States
facility: US215
state: New Jersey
city: Toms River
country: United States
facility: US209
state: New Jersey
city: West Long Branch
country: United States
facility: US036
state: New Jersey
city: Albany
country: United States
facility: US001
state: New York
city: Brooklyn
country: United States
facility: US049
state: New York
city: New Hyde Park
country: United States
facility: US097
state: New York
city: New Windsor
country: United States
facility: US177
state: New York
city: New York
country: United States
facility: US142
state: New York
city: New York
country: United States
facility: US044
state: New York
city: Chapel Hill
country: United States
facility: US150
state: North Carolina
city: Charlotte
country: United States
facility: US185
state: North Carolina
city: Beachwood
country: United States
facility: US113
state: Ohio
city: Cincinnati
country: United States
facility: US136
state: Ohio
city: Cincinnati
country: United States
facility: US008
state: Ohio
city: Shaker Heights
country: United States
facility: US119
state: Ohio
city: Portland
country: United States
facility: US134
state: Oregon
city: Media
country: United States
facility: US169
state: Pennsylvania
city: Philadelphia
country: United States
facility: US187
state: Pennsylvania
city: Plains
country: United States
facility: US162
state: Pennsylvania
city: Willow Grove
country: United States
facility: US148
state: Pennsylvania
city: Houston
country: United States
facility: US115
state: Texas
city: San Antonio
country: United States
facility: US043
state: Texas
city: Orem
country: United States
facility: US143
state: Utah
city: Charlottesville
country: United States
facility: US149
state: Virginia
city: Spokane
country: United States
facility: US170
state: Washington
city: La Plata
country: Argentina
facility: AR130
state: Buenos Aires
city: La Plata
country: Argentina
facility: AR041
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: AR101
city: Buenos Aires
country: Argentina
facility: AR060
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR084
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR027
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR012
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR160
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR040
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR028
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR081
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: AR035
city: Cordoba
country: Argentina
facility: AR051
city: Cordoba
country: Argentina
facility: AR137
city: Mendoza
country: Argentina
facility: AR210
city: Mendoza
country: Argentina
facility: AR219
city: Santiago del Estero
country: Argentina
facility: AR059
city: Caulfield
country: Australia
facility: AU227
city: Chermside
country: Australia
facility: AU079
city: Heidelberg West
country: Australia
facility: AU032
city: Herston
country: Australia
facility: AU062
city: Hornsby
country: Australia
facility: AU011
city: West Perth
country: Australia
facility: AU138
city: Ruse
country: Bulgaria
facility: BU125
city: Sofia
country: Bulgaria
facility: BU131
city: Sofia
country: Bulgaria
facility: BU198
city: Varna
country: Bulgaria
facility: BU073
city: Medicine Hat
country: Canada
facility: CA151
state: Alberta
city: Kamloops
country: Canada
facility: CA120
state: British Columbia
city: Kelowna
country: Canada
facility: CA054
state: British Columbia
city: Kelowna
country: Canada
facility: CA188
state: British Columbia
city: Penticton
country: Canada
facility: CA186
state: British Columbia
city: West Vancouver
country: Canada
facility: CA141
state: British Columbia
city: Newmarket
country: Canada
facility: CA147
state: Ontario
city: North York
country: Canada
facility: CA196
state: Ontario
city: Toronto
country: Canada
facility: CA237
state: Ontario
city: Gatineau
country: Canada
facility: CA236
state: Quebec
city: Antofagasta
country: Chile
facility: CH212
state: II Región
city: Santiago
country: Chile
facility: CH076
state: Region Metropolitana
city: Santiago
country: Chile
facility: CH061
state: Región Metropolitana
city: Santiago
country: Chile
facility: CH075
state: Región Metropolitana
city: Zagreb
country: Croatia
facility: CR069
city: Zagreb
country: Croatia
facility: CR122
city: Zagreb
country: Croatia
facility: CR068
city: Zagreb
country: Croatia
facility: CR070
city: Zagreb
country: Croatia
facility: CR083
city: Praha 10
country: Czechia
facility: CZ128
city: Praha 10
country: Czechia
facility: CZ207
city: Praha 2
country: Czechia
facility: CZ132
city: Praha 6
country: Czechia
facility: CZ129
city: Rychnov nad Kneznou
country: Czechia
facility: CZ161
city: Lille Cedex
country: France
facility: FR231
city: Marseille Cedex 5
country: France
facility: FR182
city: Paris Cedex
country: France
facility: FR221
city: Villeurbanne
country: France
facility: FR202
city: Bad Homburg
country: Germany
facility: GE206
city: Berlin
country: Germany
facility: GE091
city: Berlin
country: Germany
facility: GE071
city: Berlin
country: Germany
facility: GE139
city: Cologne
country: Germany
facility: GE230
city: Ellwangen
country: Germany
facility: GE252
city: Leipzig
country: Germany
facility: GE180
city: Mannheim
country: Germany
facility: GE228
city: Munchen
country: Germany
facility: GE017
city: Nürnberg
country: Germany
facility: GE157
city: Ulm
country: Germany
facility: GE098
city: Westerstede
country: Germany
facility: GE251
city: Brescia
country: Italy
facility: IT053
city: Cefalù
country: Italy
facility: IT124
city: Pavia
country: Italy
facility: IT030
city: Perugia
country: Italy
facility: IT103
city: Roma
country: Italy
facility: IT072
city: Roma
country: Italy
facility: IT183
city: Roma
country: Italy
facility: IT029
city: Rome
country: Italy
facility: IT175
city: Torino
country: Italy
facility: IT085
city: Busan
country: Korea, Republic of
facility: SK066
city: Seoul
country: Korea, Republic of
facility: SK067
city: Seoul
country: Korea, Republic of
facility: SK190
city: Bialystok
country: Poland
facility: PO013
city: Bydgoszcz
country: Poland
facility: PO024
city: Bydgoszcz
country: Poland
facility: PO010
city: Katowice
country: Poland
facility: PO107
city: Katowice
country: Poland
facility: PO092
city: Krakow
country: Poland
facility: PO023
city: Krakow
country: Poland
facility: PO025
city: Poznan
country: Poland
facility: PO009
city: Szczecin
country: Poland
facility: PO014
city: Warszawa
country: Poland
facility: PO074
city: Belgrade
country: Serbia
facility: SE164
city: Belgrade
country: Serbia
facility: SE090
city: Belgrade
country: Serbia
facility: SE166
city: Belgrade
country: Serbia
facility: SE193
city: Kragujevac
country: Serbia
facility: SE155
city: Novi Knezevac
country: Serbia
facility: SE031
city: Vrsac
country: Serbia
facility: SE165
city: Singapore
country: Singapore
facility: SI052
city: Singapore
country: Singapore
facility: SI026
city: Banska Bystrica
country: Slovakia
facility: SL056
city: Bratislava
country: Slovakia
facility: SL192
city: Dubnica nad Váhom
country: Slovakia
facility: SL200
city: Kosice
country: Slovakia
facility: SL191
city: Krompachy
country: Slovakia
facility: SL078
city: Svidnik
country: Slovakia
facility: SL077
city: Alicante
country: Spain
facility: SP249
city: Barcelona
country: Spain
facility: SP176
city: Barcelona
country: Spain
facility: SP022
city: Barcelona
country: Spain
facility: SP021
city: Barcelona
country: Spain
facility: SP250
city: Ceuta
country: Spain
facility: SP019
city: Donostia
country: Spain
facility: SP194
city: Getxo
country: Spain
facility: SP222
city: Madrid
country: Spain
facility: SP018
city: Madrid
country: Spain
facility: SP093
city: Sant Cugat del Vallès
country: Spain
facility: SP184
city: Terrassa
country: Spain
facility: SP020
city: Kaohsiung
country: Taiwan
facility: TA065
city: Taipei
country: Taiwan
facility: TA086
city: Taoyuan
country: Taiwan
facility: TA121
city: Bath
country: United Kingdom
facility: UK063
city: Blackpool
country: United Kingdom
facility: UK038
city: Cambridge
country: United Kingdom
facility: UK233
city: Cannock
country: United Kingdom
facility: UK033
city: Epping
country: United Kingdom
facility: UK211
city: Guildford
country: United Kingdom
facility: UK234
city: Leeds
country: United Kingdom
facility: UK055
city: London
country: United Kingdom
facility: UK039
city: Manchester
country: United Kingdom
facility: UK034
city: Norwich
country: United Kingdom
facility: UK229
city: Oxford
country: United Kingdom
facility: UK087
city: Plymouth
country: United Kingdom
facility: UK235
city: Sheffield
country: United Kingdom
facility: UK100
city: Southampton
country: United Kingdom
facility: UK064
city: Southampton
country: United Kingdom
facility: UK152
city: Swindon
country: United Kingdom
facility: UK153
city: Warrington
country: United Kingdom
facility: UK154
Study officials:
affiliation: Axovant Sciences, Inc., Vice President, Clinical Research
name: Ilise Lombardo, MD
role: STUDY_DIRECTOR
References: