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Alzheimer's DiseasePhase 3NCT02585934

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

A Phase 3 study testing RVT-101 in people with Alzheimer's Disease, run by Axovant Sciences Ltd. at 197 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
RVT-101
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,315 participants
Where
197 sitesin 19 countries
Study dates
Oct 2015to Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

197 sites in 19 countries.

197 sites in 19 countries

United States61 sites

  • US001

    Albany, New York, 12208

  • US048

    Atlanta, Georgia, 30331

  • US046

    Atlanta, Georgia, 30342

  • US088

    Atlantis, Florida, 33462

  • US111

    Baton Rouge, Louisiana, 70808

  • US113

    Beachwood, Ohio, 44122

  • US135

    Berlin, New Jersey, 08009

  • US049

    Brooklyn, New York, 11235

  • US007

    Brooksville, Florida, 34601

  • US150

    Chapel Hill, North Carolina, 27599

  • US185

    Charlotte, North Carolina, 28270

  • US149

    Charlottesville, Virginia, 22903

  • US136

    Cincinnati, Ohio, 45220

  • US008

    Cincinnati, Ohio, 45227

  • US217

    Columbus, Georgia, 31909

  • US168

    Encino, California, 91436

  • US117

    Fullerton, California, 92835

  • US002

    Hallandale, Florida, 33009

  • US179

    Hamden, Connecticut, 06518

  • US144

    Hattiesburg, Mississippi, 39401

  • US140

    Hialeah, Florida, 33012

  • US115

    Houston, Texas, 77074

  • US094

    Las Vegas, Nevada, 89113

  • US197

    Lawrenceville, New Jersey, 08648

  • US214

    Los Angeles, California, 90024

  • US169

    Media, Pennsylvania, 19063

  • US216

    Miami, Florida, 33137

  • US110

    Miami, Florida, 33165

  • US215

    Mount Arlington, New Jersey, 07856

  • US097

    New Hyde Park, New York, 11040

  • US177

    New Windsor, New York, 12553

  • US142

    New York, New York, 10021

  • US044

    New York, New York, 10022

  • US116

    Newton, Massachusetts, 02459

  • US172

    North Palm Beach, Florida, 33408

  • US171

    Norwich, Connecticut, 06360

  • US143

    Orem, Utah, 84058

  • US003

    Orlando, Florida, 32806

  • US189

    Pasadena, California, 91105

  • US057

    Paterson, New Jersey, 08759

  • US256

    Pensacola, Florida, 32502

  • US187

    Philadelphia, Pennsylvania, 19102

  • US112

    Phoenix, Arizona, 85005

  • US162

    Plains, Pennsylvania, 18075

  • US134

    Portland, Oregon, 97210

  • US174

    Quincy, Massachusetts, 02169

  • US096

    Rancho Mirage, California, 92270

  • US043

    San Antonio, Texas, 78229

  • US0195

    Santa Ana, California, 92705

  • US119

    Shaker Heights, Ohio, 44122

  • US095

    Shreveport, Louisiana, 71104

  • US016

    Simi Valley, California, 93065

  • US170

    Spokane, Washington, 99202

  • US037

    Tampa, Florida, 33613

  • US042

    Tampa, Florida, 33613

  • US106

    Temecula, California, 92591

  • US004

    The Villages, Florida, 32162

  • US209

    Toms River, New Jersey, 08755

  • US220

    Tucson, Arizona, 85704

  • US036

    West Long Branch, New Jersey, 07764

  • US148

    Willow Grove, Pennsylvania, 19001

Other trials in United States

Argentina17 sites

  • AR101

    Buenos Aires, B1828CKR

  • AR060

    Buenos Aires, C1199ABB

  • AR084

    Ciudad Autónoma de Buenos Aire, C1012AAR

  • AR027

    Ciudad Autónoma de Buenos Aire, C1058AAJ

  • AR012

    Ciudad Autónoma de Buenos Aire, C1111AAL

  • AR160

    Ciudad Autónoma de Buenos Aire, C1117ABH

  • AR040

    Ciudad Autónoma de Buenos Aire, C1405BCK

  • AR028

    Ciudad Autónoma de Buenos Aire, C1406BOA

  • AR081

    Ciudad Autónoma de Buenos Aire, C1425AHQ

  • AR035

    Ciudad Autónoma de Buenos Aire, C1428AQK

  • AR051

    Córdoba, X5000DCE

  • AR137

    Córdoba, X5000FJF

  • AR130

    La Plata, Buenos Aires, A1902AJU

  • AR041

    La Plata, Buenos Aires, B1900BOM

  • AR210

    Mendoza, M5501ACP

  • AR219

    Mendoza, M5502AHV

  • AR059

    Santiago del Estero, G4200DND

Other trials in Argentina

United Kingdom17 sites

  • UK063

    Bath, BA1 3NG

  • UK038

    Blackpool, FY2 0JH

  • UK233

    Cambridge, CB21 5EF

  • UK033

    Cannock, WS11 0BN

  • UK211

    Epping, CM16 6TN

  • UK234

    Guildford, GU2 7YD

  • UK055

    Leeds, LS10 1DU

  • UK039

    London, W1G 9JF

  • UK034

    Manchester, M13 9NQ

  • UK229

    Norwich, NR2 3TD

  • UK087

    Oxford, OX3 9DU

  • UK235

    Plymouth, PL5 8BT

  • UK100

    Sheffield, S5 7JT

  • UK064

    Southampton, SO16 6YD

  • UK152

    Southampton, SO30 3JB

  • UK153

    Swindon, SN3 6BW

  • UK154

    Warrington, WA22 8WA

Other trials in United Kingdom

Germany12 sites

  • GE206

    Bad Homburg, 61348

  • GE091

    Berlin, 10117

  • GE071

    Berlin, 12203

  • GE139

    Berlin, 13125

  • GE230

    Cologne, 50937

  • GE252

    Ellwangen, 73479

  • GE180

    Leipzig, 04107

  • GE228

    Mannheim, 68165

  • GE017

    München, 81675

  • GE157

    Nuremberg, 90402

  • GE098

    Ulm, 89081

  • GE251

    Westerstede, 26655

Other trials in Germany

Spain12 sites

  • SP249

    Alicante, 03690

  • SP176

    Barcelona, 08003

  • SP022

    Barcelona, 08028

  • SP021

    Barcelona, 08035

  • SP250

    Barcelona, 08036

  • SP019

    Ceuta, 51003

  • SP194

    Donostia / San Sebastian, 20014

  • SP222

    Getxo, 48993

  • SP018

    Madrid, 28040

  • SP093

    Madrid, 28046

  • SP184

    Sant Cugat del Vallès, 08190

  • SP020

    Terrassa, 08221

Other trials in Spain

Canada10 sites

  • CA236

    Gatineau, Quebec, J8T8JI

  • CA120

    Kamloops, British Columbia, V2C 1K7

  • CA054

    Kelowna, British Columbia, V1Y 1Z9

  • CA188

    Kelowna, British Columbia, V1Y 4N7

  • CA151

    Medicine Hat, Alberta, T1B4E7

  • CA147

    Newmarket, Ontario, L3Y 5G8

  • CA196

    North York, Ontario, M3B 2S7

  • CA186

    Penticton, British Columbia, V2A 5C8

  • CA237

    Toronto, Ontario, M4G 0A1

  • CA141

    West Vancouver, British Columbia, V7T 2Z3

Other trials in Canada

Poland10 sites

  • PO013

    Bialystok, 15-756

  • PO024

    Bydgoszcz, 85-080

  • PO010

    Bydgoszcz, 85-796

  • PO107

    Katowice, 40-123

  • PO092

    Katowice, 40-749

  • PO023

    Krakow, 30-349

  • PO025

    Krakow, 35-505

  • PO009

    Poznan, 61-853

  • PO014

    Szczecin, 70-111

  • PO074

    Warsaw, 01-697

Other trials in Poland

Italy9 sites

  • IT053

    Brescia, 25125

  • IT124

    Cefalù, 90015

  • IT030

    Pavia, 27100

  • IT103

    Perugia, 06156

  • IT072

    Roma, 00168

  • IT183

    Roma, 00179

  • IT029

    Roma, 00189

  • IT175

    Rome, 00185

  • IT085

    Torino, 10 126

Other trials in Italy

Serbia7 sites

  • SE164

    Belgrade, 11 000

  • SE090

    Belgrade, 11000

  • SE166

    Belgrade, 11000

  • SE193

    Belgrade, 11000

  • SE155

    Kragujevac, 34000

  • SE031

    Novi Kneževac, 23330

  • SE165

    Vršac, 26300

Other trials in Serbia

Australia6 sites

  • AU227

    Caulfield, VIC3162

  • AU079

    Chermside, QLD 4032

  • AU032

    Heidelberg West, VIC 3081

  • AU062

    Herston, QLD 4209

  • AU011

    Hornsby, NSW 2077

  • AU138

    West Perth, WA 6005

Other trials in Australia

Slovakia6 sites

  • SL056

    Banská Bystrica, 97404

  • SL192

    Bratislava, 820 07

  • SL200

    Dubnica nad Váhom, 01841

  • SL191

    Košice, 040 17

  • SL078

    Krompachy, 05342

  • SL077

    Svidník, 08901

Other trials in Slovakia

Croatia5 sites

  • CR069

    Zagreb, 10000

  • CR122

    Zagreb, 10000

  • CR068

    Zagreb, 10090

  • CR070

    Zagreb, 10090

  • CR083

    Zagreb, 10090

Other trials in Croatia

Czechia5 sites

  • CZ128

    Prague, 100 00

  • CZ207

    Prague, 109 00

  • CZ132

    Prague, 120 00

  • CZ129

    Prague, 160 00

  • CZ161

    Rychnov nad Kněžnou, 516 01

Other trials in Czechia

Bulgaria4 sites

  • BU125

    Rousse, 7003

  • BU131

    Sofia, 1431

  • BU198

    Sofia, 1632

  • BU073

    Varna, 9000

Other trials in Bulgaria

Chile4 sites

  • CH212

    Antofagasta, Antofagasta, 1270244

  • CH061

    Santiago, Santiago Metropolitan, 7510186

  • CH075

    Santiago, Santiago Metropolitan, 7520338

  • CH076

    Santiago, Santiago Metropolitan, 7560356

Other trials in Chile

France4 sites

  • FR231

    Lille, 59037

  • FR182

    Marseille, 13385

  • FR221

    Paris, 75013

  • FR202

    Villeurbanne, 69 100

Other trials in France

South Korea3 sites

  • SK066

    Busan, 49201

  • SK067

    Seoul, 06351

  • SK190

    Seoul, 07061

Other trials in South Korea

Taiwan3 sites

  • TA065

    Kaohsiung City, 833

  • TA086

    Taipei, 100

  • TA121

    Taoyuan, 333

Other trials in Taiwan

Singapore2 sites

  • SI052

    Singapore, 119074

  • SI026

    Singapore, 308433

Other trials in Singapore

About this 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

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.

Read the 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.

Being tested
RVT-101, Placebo
Keywords
Alzheimer's disease, RVT-101, donepezil, intepirdine, dementia
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RVT-101Drug

    once daily, oral, 35 mg tablets

  • PlaceboDrug

    once daily, oral, pill manufactured to match RVT-101 35 mg tablet

Study groups in NCT02585934
Study groupRoleWhat they receive
RVT-101ExperimentalRVT-101 adjunct to 5 mg or 10 mg donepezil
Receives: Drug: RVT-101
PlaceboPlacebo comparatorPlacebo adjunct to 5 mg or 10 mg donepezil
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24

    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.

    Measured: Baseline, 24 weeks

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24

    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

    Measured: Baseline, 24 weeks

Secondary outcomes (5)

  1. Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24

    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

    Measured: 24 weeks

  2. The Dependence Scale (DS) Score Change From Baseline to Week 24

    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.

    Measured: Baseline, 24 weeks

  3. Neuropsychiatric Inventory (NPI) Score Change From Baseline to 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.

    Measured: Baseline and Week 24

  4. ADAS-Cog-13 Score Change From Baseline to Week 24

    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.

    Measured: Baseline, 24 weeks

  5. Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma

    Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24

    Measured: Week 6, Week 12, Week 18, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585934
Sponsor's protocol ID
RVT-101-3001
Status last verified
Nov 2018
First submitted
22 Oct 2015
Last updated
5 Dec 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RVT-101 in people with Alzheimer's Disease, run by Axovant Sciences Ltd. at 197 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 197 sites in United States, Argentina, United Kingdom, Germany, Spain and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018; AzTrials last refreshed its copy on 2 Nov 2026.

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