Dementia With Lewy BodiesPhase 2NCT02669433
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
A Phase 2 study testing RVT-101 35 mg and RVT-101 70 mg in people with Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 65 sites in 7 countries.
Trial summary
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Dementia With Lewy Bodies
- What is being tested?
- RVT-101 35 mg and RVT-101 70 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 65 sitesin 7 countries
- Study dates
- Jan 2016to Dec 2017
- Phase
- Phase 2
- 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 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
Who cannot join
- 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.
Trial locations and contacts
65 sites in 7 countries.
65 sites in 7 countries
United States31 sites
US136
Atlanta, Georgia, 30331
US104
Boca Raton, Florida, 33431
US116
Boca Raton, Florida, 33486
US100
Chapel Hill, North Carolina, 27514
US101
Charlottesville, Virginia, 22908
US112
Chicago, Illinois, 60612
US110
Cleveland, Ohio, 44195
US106
Columbus, Ohio, 43210
US124
Dallas, Texas, 75390
US141
Englewood, Colorado, 80113
US118
Indianapolis, Indiana, 46202
US119
Irvine, California, 92868
US111
Jacksonville, Florida, 32224
US105
Lexington, Kentucky, 40536
US109
New York, New York, 10032
US135
Newton, Massachusetts, 02459
US122
Orlando, Florida, 32806
US134
Oxnard, California, 93030
US137
Palm Beach Gardens, Florida, 33410
US138
Phoenix, Arizona, 85006
US108
Phoenix, Arizona, 85013
US131
Portland, Oregon, 97210
US130
Quincy, Massachusetts, 02196
US133
Rancho Mirage, California, 92270
US102
Rochester, Minnesota, 55905
US140
Sacramento, California, 95816
US139
Sun City, Arizona, 85351
US126
Tampa, Florida, 33609
US125
Tucson, Arizona, 85704
US123
Washington D.C., District of Columbia, 20007
US120
Willow Grove, Pennsylvania, 19090
France10 sites
FR954
Bron, 69677
FR957
Lille, Nord, 59037
FR959
Paris, 75010
FR956
Paris, 75013
FR960
Paris, 75013
FR953
Saint-Herblain, 44800
FR950
Strasbourg, 67000
FR952
Toulouse, Haute-Garonne, 31052
FR955
Vandœuvre-lès-Nancy, 54500
FR951
Villeurbanne, Rhône, 69100
United Kingdom10 sites
UK807
Bristol, BS10 5NB
UK801
Cambridge, Cambridgeshire, CB21 5EF
UK806
Dundee, DD1 9SY
UK808
Epping, Essex, CM16 6TN
UK805
Isleworth, TW76FY
UK800
London, SE5 8AF
UK809
London, W1G 9RU
UK802
Manchester, M8 5RB
UK803
Newcastle upon Tyne, NE4 5PL
UK804
Southampton, Hampshire, SO30 3JB
Italy6 sites
IT302
Brescia, Lombardy, 25125
IT306
Brescia, 25123
IT300
Genoa, Liguria, 16132
IT301
Milan, 20133
IT304
Tricase, Lecce, 73039
IT305
Venice, I-30126
Netherlands3 sites
NE401
's-Hertogenbosch, 5223 GZ
NE402
Amsterdam, North Holland, 1081 HV
NE400
Rotterdam, 3015 CE
About this study
Official title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.
Read the 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).
- Conditions
- Dementia With Lewy Bodies
- Being tested
- RVT-101 35 mg, RVT-101 70 mg, Placebo
- Keywords
- Dementia with Lewy bodies, Lewy bodies, intepirdine, RVT-101, dementia
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVT-101 35 mgDrug
once daily, oral, 35-mg tablets
RVT-101 70 mgDrug
once daily, oral, 35-mg tablets
PlaceboDrug
once daily, oral, matching tablets
| Study group | Role | What they receive |
|---|---|---|
| RVT-101 35 mg | Experimental | RVT-101 35 mg once daily Receives: Drug: RVT-101 35 mg |
| RVT-101 70 mg | Experimental | RVT-101 70 mg once daily Receives: Drug: RVT-101 70 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
Measured: Change from Baseline at 24 weeks
Secondary outcomes (2)
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at 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: Change from Baseline at 24 weeks
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.
Measured: Change from Baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
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 Dementia With Lewy BodiesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 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., Senior Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669433
- Sponsor's protocol ID
- RVT-101-2001
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2016
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)
- ClinicalTrials.gov ID
- NCT02669433
- Acronym / sponsor ID
- RVT-101-2001
- Conditions
- Dementia With Lewy Bodies
- Keywords
- Dementia with Lewy bodies, Lewy bodies, intepirdine, RVT-101, dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Axovant Sciences Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RVT-101 35 mg | Experimental | Drug: RVT-101 35 mgRVT-101 35 mg once daily |
| RVT-101 70 mg | Experimental | Drug: RVT-101 70 mgRVT-101 70 mg once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
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 mgonce daily, oral, 35-mg tablets | Drug | RVT-101 35 mg |
| RVT-101 70 mgonce daily, oral, 35-mg tablets | Drug | RVT-101 70 mg |
| Placeboonce daily, oral, matching tablets | Drug | Placebo |
Primary outcome
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24
Time frame: Change from Baseline at 24 weeks
The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
2 secondary outcomes
Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24
Time frame: Change from Baseline at 24 weeks
Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24
Time frame: Change from Baseline at 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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., Senior Vice President, Clinical Research
65 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVT-101 35 mg and RVT-101 70 mg in people with Dementia With Lewy Bodies, run by Axovant Sciences Ltd. at 65 sites in 7 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 5 inclusion and 2 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 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, France, United Kingdom, Italy, Netherlands and 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 26 Apr 2019). 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?
Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24 (time frame: Change from Baseline at 24 weeks). 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 26 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.