VI-1121 for the Treatment Alzheimer's Disease

NCT01428362 — Phase 2, Completed, 61 participants, VIVUS LLC

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

Registry	NCT01428362, acronym AD-201
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, crossover, masking: quadruple, treatment
Enrollment	61 (Actual)
Sponsor	VIVUS LLC (Industry); collaborators: Medpace, Inc.
Conditions	Alzheimer's Disease
Interventions	VI-1121, Placebo (Drug)
Dates	start 2011-08-01, primary completion 2013-08-01, completion 2013-08-01, first posted 2011-09-05, last updated 2013-12-11
Locations	11 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Placebo/VI-1121	Experimental	Drug: VI-1121; Drug: Placebo	Subjects 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: Placebo	Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.

VI-1121 (Drug)
Placebo (Drug)

+Outcome measures

Primary outcomes

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. [12 weeks]

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. [12 weeks]
Percentage of subjects who achieve 3-point improvement in ADAS-Cog score from baseline to Week 12 of each treatment period. [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 [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 [4, 8, and 12 Weeks]

+Eligibility

Sex: All, ages: 60 Years to 85 Years

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

+Locations (11)

Facility	City	Country	Status
	San Francisco, California	United States
	Santa Monica, California	United States
	Sunrise, Florida	United States
	Louisville, Kentucky	United States
	Las Vegas, Nevada	United States
	Toms River, New Jersey	United States
	New Windsor, New York	United States
	Durham, North Carolina	United States
	Raleigh, North Carolina	United States
	Toledo, Ohio	United States
	Plano, Texas	United States

My Notes

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