Alzheimer's DiseasePhase 2AD-201NCT01428362
VI-1121 for the Treatment Alzheimer's Disease
A Phase 2 study testing VI-1121 in people with Alzheimer's Disease, run by VIVUS LLC at 11 sites in United States.
Trial summary
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- VI-1121
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 11 sitesUnited States
- Study dates
- Aug 2011to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of Alzheimer's disease
- CT or MRI within 2 years prior to study
- stable dose of current Alzheimer's treatment for at least 3 months
Who cannot join
- advanced, severe, progressive or unstable disease
- history of cerebrovascular disease or myocardial infarction within 6 months
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Durham, North Carolina, 27710
Study site
Las Vegas, Nevada, 89113
Study site
Louisville, Kentucky, 40217
Study site
New Windsor, New York, 12553
Study site
Plano, Texas, 75075
Study site
Raleigh, North Carolina, 27612
Study site
San Francisco, California, 94109
Study site
Santa Monica, California, 90404
Study site
Sunrise, Florida, 33351
Study site
Toledo, Ohio, 43623
Study site
Toms River, New Jersey, 08755
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.
- Conditions
- Alzheimer's Disease
- Being tested
- VI-1121, Placebo
- Keywords
- donepezil, VI-1121
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VI-1121Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo/VI-1121 | Experimental | Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period. Receives: Drug: VI-1121; Drug: Placebo |
| VI-1121/Placebo | Experimental | Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period. Receives: Drug: VI-1121; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period.
Measured: 12 weeks
Secondary outcomes (4)
The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
Measured: 12 weeks
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
Measured: 12 Weeks
Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period
Measured: 12 Weeks
Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period
Measured: 4, 8, and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVUS LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428362
- Sponsor's protocol ID
- AD-201
- Acronym
- AD-201
- Status last verified
- Nov 2013
- First submitted
- 31 Aug 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01428362
- Acronym / sponsor ID
- AD-201 / AD-201
- Conditions
- Alzheimer's Disease
- Keywords
- donepezil, VI-1121
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- VIVUS LLCIndustry (pharma, biotech, devices)
- Collaborators
- Medpace, Inc.
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether VI-1121 is safe, well tolerated, and effective as a daily treatment for Alzheimer's disease that is worsening despite current treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo/VI-1121 | Experimental | Drug: VI-1121, Drug: PlaceboSubjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period. |
| VI-1121/Placebo | Experimental | Drug: VI-1121, Drug: PlaceboSubjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of Alzheimer's disease
- CT or MRI within 2 years prior to study
- stable dose of current Alzheimer's treatment for at least 3 months
Key exclusion criteria (2 listed)
- advanced, severe, progressive or unstable disease
- history of cerebrovascular disease or myocardial infarction within 6 months
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 |
|---|---|---|
| VI-1121 | Drug | Placebo/VI-1121, VI-1121/Placebo |
| Placebo | Drug | Placebo/VI-1121, VI-1121/Placebo |
Primary outcome
The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period.
Time frame: 12 weeks
4 secondary outcomes
The secondary efficacy endpoint is the mean change in Mini-Mental State Examination (MMSE) score from baseline to Week 12 of each treatment period.
Time frame: 12 weeks
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period.
Time frame: 12 Weeks
Change in Clinician's Interview Based Impression of Change Plus Caregiver's Input (CIBIC-plus) score from baseline to Week 12 of each treatment period
Time frame: 12 Weeks
Mean change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score from baseline to Weeks 4, 8, and 12 of each treatment period
Time frame: 4, 8, and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VI-1121 in people with Alzheimer's Disease, run by VIVUS LLC at 11 sites in United States.
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 3 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 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy variable is the change in Alzheimer's Disease Assessment-Cognitive Subscale (ADAS-Cog) score from baseline to Week 12 of each treatment period. (time frame: 12 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 11 Dec 2013.