AD-201

CompletedPhase 2

VI-1121 for the Treatment Alzheimer's Disease

A Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Safety, Tolerability and Efficacy of VI-1121 in Subjects With Alzheimer's Disease

Lead sponsor

VIVUS LLC

Asset

VI-1121

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAD-201

NCT IDNCT01428362

Timeline

Milestones

Study start2011-08 (month precision)

Study first posted2011-09-05estimated

Primary completion2013-08actual (month precision)

Study completion2013-08actual (month precision)

Last update posted2013-12-11estimated

Assets

Drug assets

VI-1121

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•advanced, severe, progressive or unstable disease

•history of cerebrovascular disease or myocardial infarction within 6 months

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Caregiver / quality of life

Global cognition

3 endpoints

Primary/protocol endpoint

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

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

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

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.