VI-1121 for the Treatment Alzheimer's Disease (AD-201)

Vivus

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: VI-1121

Study type: Interventional

Funder types: Industry

Identifiers

NCT01428362

AD-201

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups

Placebo/VI-1121

Experimental group

Description:

Subjects received placebo during first treatment period and active treatment with VI-1121 during the second treatment period.

Treatment:

Drug: Placebo

Drug: VI-1121

VI-1121/Placebo

Experimental group

Description:

Subjects received active treatment with VI-1121 during the first treatment period and placebo during the second treatment period.

Treatment:

Drug: Placebo

Drug: VI-1121