Alzheimer's DiseasePhase 3NCT02586909
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension
A Phase 3 study testing RVT-101 35 mg tablets in people with Alzheimer's Disease, run by Axovant Sciences Ltd. at 169 sites in 19 countries.
Trial summary
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study). Read more about this study
- Who is it for?
- Ages 50 to 86 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- RVT-101 35 mg tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,099 participants
- Where
- 169 sitesin 19 countries
- Study dates
- 26 Apr 2016to 12 Mar 2018
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed last on-treatment visit of the lead-in study RVT-101-3001
Who cannot join
- 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
169 sites in 19 countries.
169 sites in 19 countries
United States52 sites
US001
Albany, New York, 12208
US048
Atlanta, Georgia, 30331
US046
Atlanta, Georgia, 30342
US088
Atlantis, Florida, 33462
US111
Baton Rouge, Louisiana, 70808
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
US008
Cincinnati, Ohio, 45227
US113
Cleveland, Ohio, 44106
US217
Columbus, Georgia, 31909
US002
Hallandale, Florida, 33009
US179
Hamden, Connecticut, 06518
US144
Hattiesburg, Mississippi, 39401
US140
Hialeah, Florida, 33012
US094
Las Vegas, Nevada, 89113
US197
Lawrenceville, New Jersey, 08648
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
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
US057
Paterson, New Jersey, 08759
US256
Pensacola, Florida, 32502
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
US195
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
Argentina17 sites
AR101
Buenos Aires, B1828CKR
AR060
Buenos Aires, C1199ABB
AR084
Ciudad Autonoma de Buenos Aire, C1012AAR
AR027
Ciudad Autonoma de Buenos Aire, C1058AAJ
AR012
Ciudad Autonoma de Buenos Aire, C1111AAL
AR160
Ciudad Autonoma de Buenos Aire, C1117ABH
AR028
Ciudad Autonoma de Buenos Aire, C1406BOA
AR035
Ciudad Autonoma de Buenos Aire, C1428AQK
AR040
Ciudad Autónoma de Buenos Aire, C1405BCK
AR081
Ciudad Autónoma de Buenos Aire, C1425AHQ
AR051
Córdoba, X5000DCE
AR137
Córdoba, X5000FJF
AR126
Córdoba, X5004AOA
AR130
La Plata, Buenos Aires, A1902AJU
AR210
Mendoza, M5501ACP
AR219
Mendoza, M5502AHV
AR059
Santiago del Estero, G4200DND
United Kingdom16 sites
UK063
Bath, BA1 3NG
UK038
Blackpool, FY2 0JH
UK233
Cambridge, CB21 5EF
UK033
Carnoch, WS11 0BN
UK211
Epping, CM16 6TN
UK234
Guildford, GU2 7YD
UK055
Leeds, LS10 1DU
UK039
London, W1G 9RU
UK034
Manchester, M13 9NQ
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
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
Italy9 sites
IT053
Brescia, 25125
IT124
Cefalù, 90015
IT030
Pavia, 27100
IT103
Perugia, 06156
IT072
Roma, 00168
IT029
Roma, 00189
IT183
Rome, 00179
IT175
Rome, 00185
IT085
Torino, 10 126
Poland8 sites
PO013
Bialystok, 15-756
PO024
Bydgoszcz, 85-080
PO010
Bydgoszcz, 85-796
PO107
Katowice, 40-123
PO092
Katowice, 40-749
PO009
Poznan, 61-853
PO014
Szczecin, 70-111
PO074
Warsaw, 01-697
Spain8 sites
SP249
Alicante, 03690
SP176
Barcelona, 08003
SP022
Barcelona, 08028
SP021
Barcelona, 08035
SP250
Barcelona, 08036
SP184
Barcelona, 08195
SP222
Getxo, 48993
SP194
San Sebastián, 20014
Canada7 sites
CA236
Gatineau, Quebec, J8T 8JI
CA054
Kelowna, British Columbia, V1Y 1Z9
CA188
Kelowna, British Columbia, V1Y 4N7
CA147
Newmarket, Ontario, L3Y 5G8
CA196
North York, Ontario, M3B 2S7
CA186
Penticton, British Columbia, V2A 5C8
CA141
West Vancouver, British Columbia, V7T 2Z3
Serbia6 sites
SE164
Belgrade, 11 000
SE193
Belgrade, 11 000
SE090
Belgrade, 11000
SE155
Kragujevac, 34 000
SE031
Novi Kneževac, 23330
SE165
Vršac, 26300
Czechia5 sites
CZE128
Prague, 100 00
CZE207
Prague, 100 00
CZE132
Prague, 12000
CZE129
Prague, 160 00
CZE161
Rychnov nad Kněžnou, 516 01
Slovakia5 sites
SL056
Banská Bystrica, 974 04
SL200
Dubnica nad Váhom, 018 41
SL078
Krompachy, 040 01
SL078
Krompachy, 05342
SL077
Svidník, 08901
Australia4 sites
AU227
Caulfield, VIC 3162
AU032
Heidelberg West, VIC 3081
AU011
Hornsby, NSW 2077
AU138
West Perth, WA 6005
Chile4 sites
CH212
Antofagasta, Antofagasta, 1270244
CH061
Santiago, Santiago Metropolitan, 7510186
CH075
Santiago, Santiago Metropolitan, 7520338
CH076
Santiago, Santiago Metropolitan, 7560356
France4 sites
FR231
Lille, 59037
FR182
Marseille, 13385
FR221
Paris, 75013
FR202
Villeurbanne, 69 100
About this study
Official title: A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
Read the detailed description
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
- Conditions
- Alzheimer's Disease
- Being tested
- RVT-101 35 mg tablets
- Keywords
- Alzheimer's disease, RVT-101, donepezil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-101 35 mg tabletsDrug
once daily, oral tablets
| Study group | Role | What they receive |
|---|---|---|
| RVT-101 35 mg tablets | Experimental | once daily, oral tablets Receives: Drug: RVT-101 35 mg tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Measured: Baseline to 12 months or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start26 Apr 2016
- Primary completion12 Mar 2018
- Study completion12 Mar 2018
Why it stopped: Intepirdine did't meet primary efficacy endpoints in lead-in study RVT-101-3001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axovant Sciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ilise Lombardo, MD, Study director, Axovant Sciences, Inc., Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586909
- Sponsor's protocol ID
- RVT-101-3002
- Status last verified
- Mar 2018
- First submitted
- 23 Oct 2015
- Last updated
- 17 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02586909
- Acronym / sponsor ID
- RVT-101-3002
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, RVT-101, donepezil
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intepirdine did't meet primary efficacy endpoints in lead-in study RVT-101-3001
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- Axovant Sciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2016 (actual)
- Primary completion
- 12 Mar 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).
Detailed description
This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RVT-101 35 mg tablets | Experimental | Drug: RVT-101 35 mg tabletsonce daily, oral tablets |
Who may qualify
- Ages
- 50 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Completed last on-treatment visit of the lead-in study RVT-101-3001
Key exclusion criteria (1 listed)
- Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVT-101 35 mg tabletsonce daily, oral tablets | Drug | RVT-101 35 mg tablets |
Primary outcome
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments
Time frame: Baseline to 12 months or Early Termination
The primary outcome measure is to study the safety of Intepridine (RVT-101) by determining the incidence of AEs, changes in physical examinations, vital signs measurements, ECGs and clinical laboratory assessments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilise Lombardo, MD study director
Axovant Sciences, Inc., Vice President, Clinical Research
169 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RVT-101 35 mg tablets in people with Alzheimer's Disease, run by Axovant Sciences Ltd. at 169 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 169 sites in United States, Argentina, United Kingdom, Germany, Italy 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. 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 17 Apr 2020). 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?
Occurrence of Adverse Events (AEs) and or Reported Changes in Physical Examinations, Vital Signs Measurements, Electrocardiograms (ECGs), Routine Laboratory Assessments (time frame: Baseline to 12 months or Early Termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2020.