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Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study

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ClinicalTrials.gov Identifier: NCT02585934
Recruitment Status : Completed
First Posted : October 26, 2015
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Axovant Sciences Ltd.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: RVT-101 Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: RVT-101
RVT-101 adjunct to 5 mg or 10 mg donepezil
Drug: RVT-101
once daily, oral, 35 mg tablets

Placebo Comparator: Placebo
Placebo adjunct to 5 mg or 10 mg donepezil
Drug: Placebo
once daily, oral, pill manufactured to match RVT-101 35 mg tablet




Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 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.

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function


Secondary Outcome Measures :
  1. Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24 [ Time Frame: 24 weeks ]
    The CIBIC+ assessment measures the global functioning of the subject. The CIBIC+ is scored as a seven-point categorical rating, ranging from a score of 1 (indicating "very much improved"), to a score of 4 (indicating "no change"), or to a score of 7 (indicating "very much worse.") Lower CIBIC+ scores indicate better (more desirable) function

  2. The Dependence Scale (DS) Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    The DS measures the amount of assistance patients with dementia require in performing daily activities. The scale consists of 13 items, representing a range of severity from mild to severe levels of dependency. The score range is from 0 to 15 with higher scores indicating greater dependency.

  3. Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
    The NPI is a behavior rating scale composed of a 12-item structured interview of the caregiver that is scored from 0 to 144 (the higher the score, the greater the psychiatric disturbance). It assesses 12 behavioral disturbances occurring in dementia patients: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor activity, night-time behavior disturbances, and eating disturbances. Both the frequency and the severity of each behavior are determined.

  4. ADAS-Cog-13 Score Change From Baseline to Week 24 [ Time Frame: Baseline, 24 weeks ]
    13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.

  5. Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma [ Time Frame: Week 6, Week 12, Week 18, Week 24 ]
    Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585934


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Locations
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United States, Arizona
US112
Phoenix, Arizona, United States, 85005
US220
Tucson, Arizona, United States, 85704
United States, California
US168
Encino, California, United States, 91436
US117
Fullerton, California, United States, 92835
US214
Los Angeles, California, United States, 90024
US189
Pasadena, California, United States, 91105
US096
Rancho Mirage, California, United States, 92270
US0195
Santa Ana, California, United States, 92705
US016
Simi Valley, California, United States, 93065
US106
Temecula, California, United States, 92591
United States, Connecticut
US179
Hamden, Connecticut, United States, 06518
US171
Norwich, Connecticut, United States, 06360
United States, Florida
US088
Atlantis, Florida, United States, 33462
US007
Brooksville, Florida, United States, 34601
US002
Hallandale Beach, Florida, United States, 33009
US140
Hialeah, Florida, United States, 33012
US216
Miami, Florida, United States, 33137
US110
Miami, Florida, United States, 33165
US172
North Palm Beach, Florida, United States, 33408
US003
Orlando, Florida, United States, 32806
US256
Pensacola, Florida, United States, 32502
US037
Tampa, Florida, United States, 33613
US042
Tampa, Florida, United States, 33613
US004
The Villages, Florida, United States, 32162
United States, Georgia
US048
Atlanta, Georgia, United States, 30331
US046
Atlanta, Georgia, United States, 30342
US217
Columbus, Georgia, United States, 31909
United States, Louisiana
US111
Baton Rouge, Louisiana, United States, 70808
US095
Shreveport, Louisiana, United States, 71104
United States, Massachusetts
US116
Newton, Massachusetts, United States, 02459
US174
Quincy, Massachusetts, United States, 02169
United States, Mississippi
US144
Hattiesburg, Mississippi, United States, 39401
United States, Nevada
US094
Las Vegas, Nevada, United States, 89113
United States, New Jersey
US135
Berlin, New Jersey, United States, 08009
US197
Lawrenceville, New Jersey, United States, 08648
US057
Manchester, New Jersey, United States, 08759
US215
Mount Arlington, New Jersey, United States, 07856
US209
Toms River, New Jersey, United States, 08755
US036
West Long Branch, New Jersey, United States, 07764
United States, New York
US001
Albany, New York, United States, 12208
US049
Brooklyn, New York, United States, 11235
US097
New Hyde Park, New York, United States, 11040
US177
New Windsor, New York, United States, 12553
US142
New York, New York, United States, 10021
US044
New York, New York, United States, 10022
United States, North Carolina
US150
Chapel Hill, North Carolina, United States, 27599
US185
Charlotte, North Carolina, United States, 28270
United States, Ohio
US113
Beachwood, Ohio, United States, 44122
US136
Cincinnati, Ohio, United States, 45220
US008
Cincinnati, Ohio, United States, 45227
US119
Shaker Heights, Ohio, United States, 44122
United States, Oregon
US134
Portland, Oregon, United States, 97210
United States, Pennsylvania
US169
Media, Pennsylvania, United States, 19063
US187
Philadelphia, Pennsylvania, United States, 19102
US162
Plains, Pennsylvania, United States, 18075
US148
Willow Grove, Pennsylvania, United States, 19001
United States, Texas
US115
Houston, Texas, United States, 77074
US043
San Antonio, Texas, United States, 78229
United States, Utah
US143
Orem, Utah, United States, 84058
United States, Virginia
US149
Charlottesville, Virginia, United States, 22903
United States, Washington
US170
Spokane, Washington, United States, 99202
Argentina
AR130
La Plata, Buenos Aires, Argentina, A1902AJU
AR041
La Plata, Buenos Aires, Argentina, B1900BOM
AR101
Buenos Aires, Argentina, B1828CKR
AR060
Buenos Aires, Argentina, C1199ABB
AR084
Ciudad Autónoma de Buenos Aire, Argentina, C1012AAR
AR027
Ciudad Autónoma de Buenos Aire, Argentina, C1058AAJ
AR012
Ciudad Autónoma de Buenos Aire, Argentina, C1111AAL
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Ciudad Autónoma de Buenos Aire, Argentina, C1117ABH
AR040
Ciudad Autónoma de Buenos Aire, Argentina, C1405BCK
AR028
Ciudad Autónoma de Buenos Aire, Argentina, C1406BOA
AR081
Ciudad Autónoma de Buenos Aire, Argentina, C1425AHQ
AR035
Ciudad Autónoma de Buenos Aire, Argentina, C1428AQK
AR051
Cordoba, Argentina, X5000DCE
AR137
Cordoba, Argentina, X5000FJF
AR210
Mendoza, Argentina, M5501ACP
AR219
Mendoza, Argentina, M5502AHV
AR059
Santiago del Estero, Argentina, G4200DND
Australia
AU227
Caulfield, Australia, VIC3162
AU079
Chermside, Australia, QLD 4032
AU032
Heidelberg West, Australia, VIC 3081
AU062
Herston, Australia, QLD 4209
AU011
Hornsby, Australia, NSW 2077
AU138
West Perth, Australia, WA 6005
Bulgaria
BU125
Ruse, Bulgaria, 7003
BU131
Sofia, Bulgaria, 1431
BU198
Sofia, Bulgaria, 1632
BU073
Varna, Bulgaria, 9000
Canada, Alberta
CA151
Medicine Hat, Alberta, Canada, T1B4E7
Canada, British Columbia
CA120
Kamloops, British Columbia, Canada, V2C 1K7
CA054
Kelowna, British Columbia, Canada, V1Y 1Z9
CA188
Kelowna, British Columbia, Canada, V1Y 4N7
CA186
Penticton, British Columbia, Canada, V2A 5C8
CA141
West Vancouver, British Columbia, Canada, V7T 2Z3
Canada, Ontario
CA147
Newmarket, Ontario, Canada, L3Y 5G8
CA196
North York, Ontario, Canada, M3B 2S7
CA237
Toronto, Ontario, Canada, M4G 0A1
Canada, Quebec
CA236
Gatineau, Quebec, Canada, J8T8JI
Chile
CH212
Antofagasta, II Región, Chile, 1270244
CH076
Santiago, Region Metropolitana, Chile, 7560356
CH061
Santiago, Región Metropolitana, Chile, 7510186
CH075
Santiago, Región Metropolitana, Chile, 7520338
Croatia
CR069
Zagreb, Croatia, 10000
CR122
Zagreb, Croatia, 10000
CR068
Zagreb, Croatia, 10090
CR070
Zagreb, Croatia, 10090
CR083
Zagreb, Croatia, 10090
Czechia
CZ128
Praha 10, Czechia, 100 00
CZ207
Praha 10, Czechia, 109 00
CZ132
Praha 2, Czechia, 120 00
CZ129
Praha 6, Czechia, 160 00
CZ161
Rychnov nad Kneznou, Czechia, 516 01
France
FR231
Lille Cedex, France, 59037
FR182
Marseille Cedex 5, France, 13385
FR221
Paris Cedex, France, 75013
FR202
Villeurbanne, France, 69 100
Germany
GE206
Bad Homburg, Germany, 61348
GE091
Berlin, Germany, 10117
GE071
Berlin, Germany, 12203
GE139
Berlin, Germany, 13125
GE230
Cologne, Germany, 50937
GE252
Ellwangen, Germany, 73479
GE180
Leipzig, Germany, 04107
GE228
Mannheim, Germany, 68165
GE017
Munchen, Germany, 81675
GE157
Nürnberg, Germany, 90402
GE098
Ulm, Germany, 89081
GE251
Westerstede, Germany, 26655
Italy
IT053
Brescia, Italy, 25125
IT124
Cefalù, Italy, 90015
IT030
Pavia, Italy, 27100
IT103
Perugia, Italy, 06156
IT072
Roma, Italy, 00168
IT183
Roma, Italy, 00179
IT029
Roma, Italy, 00189
IT175
Rome, Italy, 00185
IT085
Torino, Italy, 10 126
Korea, Republic of
SK066
Busan, Korea, Republic of, 49201
SK067
Seoul, Korea, Republic of, 06351
SK190
Seoul, Korea, Republic of, 07061
Poland
PO013
Bialystok, Poland, 15-756
PO024
Bydgoszcz, Poland, 85-080
PO010
Bydgoszcz, Poland, 85-796
PO107
Katowice, Poland, 40-123
PO092
Katowice, Poland, 40-749
PO023
Krakow, Poland, 30-349
PO025
Krakow, Poland, 35-505
PO009
Poznan, Poland, 61-853
PO014
Szczecin, Poland, 70-111
PO074
Warszawa, Poland, 01-697
Serbia
SE164
Belgrade, Serbia, 11 000
SE090
Belgrade, Serbia, 11000
SE166
Belgrade, Serbia, 11000
SE193
Belgrade, Serbia, 11000
SE155
Kragujevac, Serbia, 34000
SE031
Novi Knezevac, Serbia, 23330
SE165
Vrsac, Serbia, 26300
Singapore
SI052
Singapore, Singapore, 119074
SI026
Singapore, Singapore, 308433
Slovakia
SL056
Banska Bystrica, Slovakia, 97404
SL192
Bratislava, Slovakia, 820 07
SL200
Dubnica nad Váhom, Slovakia, 01841
SL191
Kosice, Slovakia, 040 17
SL078
Krompachy, Slovakia, 05342
SL077
Svidnik, Slovakia, 08901
Spain
SP249
Alicante, Spain, 03690
SP176
Barcelona, Spain, 08003
SP022
Barcelona, Spain, 08028
SP021
Barcelona, Spain, 08035
SP250
Barcelona, Spain, 08036
SP019
Ceuta, Spain, 51003
SP194
Donostia, Spain, 20014
SP222
Getxo, Spain, 48993
SP018
Madrid, Spain, 28040
SP093
Madrid, Spain, 28046
SP184
Sant Cugat del Vallès, Spain, 08190
SP020
Terrassa, Spain, 08221
Taiwan
TA065
Kaohsiung, Taiwan, 833
TA086
Taipei, Taiwan, 100
TA121
Taoyuan, Taiwan, 333
United Kingdom
UK063
Bath, United Kingdom, BA1 3NG
UK038
Blackpool, United Kingdom, FY2 0JH
UK233
Cambridge, United Kingdom, CB21 5EF
UK033
Cannock, United Kingdom, WS11 0BN
UK211
Epping, United Kingdom, CM16 6TN
UK234
Guildford, United Kingdom, GU2 7YD
UK055
Leeds, United Kingdom, LS10 1DU
UK039
London, United Kingdom, W1G 9JF
UK034
Manchester, United Kingdom, M13 9NQ
UK229
Norwich, United Kingdom, NR2 3TD
UK087
Oxford, United Kingdom, OX3 9DU
UK235
Plymouth, United Kingdom, PL5 8BT
UK100
Sheffield, United Kingdom, S5 7JT
UK064
Southampton, United Kingdom, SO16 6YD
UK152
Southampton, United Kingdom, SO30 3JB
UK153
Swindon, United Kingdom, SN3 6BW
UK154
Warrington, United Kingdom, WA22 8WA
Sponsors and Collaborators
Axovant Sciences Ltd.
Investigators
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Study Director: Ilise Lombardo, MD Axovant Sciences, Inc., Vice President, Clinical Research
  Study Documents (Full-Text)

Documents provided by Axovant Sciences Ltd.:
Study Protocol: Protocol  [PDF] April 13, 2016


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Responsible Party: Axovant Sciences Ltd.
ClinicalTrials.gov Identifier: NCT02585934     History of Changes
Other Study ID Numbers: RVT-101-3001
First Posted: October 26, 2015    Key Record Dates
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axovant Sciences Ltd.:
Alzheimer's disease
RVT-101
donepezil
intepirdine
dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents