VI-1121 for the Treatment Alzheimer's Disease

NCT01428362 | Completed Phase 2

• 1 other identifier: AD-201
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Alzheimer's Disease

Keywords

donepezil; VI-1121

Outcome Measures

Primary Outcomes (1)

• 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 (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.

  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

Study Arms (2)

Placebo/VI-1121

EXPERIMENTAL

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

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.

Drug: VI-1121; Drug: Placebo

Interventions

VI-1121 DRUG

Placebo/VI-1121; VI-1121/Placebo

Placebo DRUG

Placebo/VI-1121; VI-1121/Placebo

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• advanced, severe, progressive or unstable disease
• history of cerebrovascular disease or myocardial infarction within 6 months

Sponsors & Collaborators

• VIVUS LLC: lead
• Medpace, Inc.: collaborator

Study Sites (11)

Unknown Facility

San Francisco, California, 94109, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Sunrise, Florida, 33351, United States

Location

Unknown Facility

Louisville, Kentucky, 40217, United States

Location

Unknown Facility

Las Vegas, Nevada, 89113, United States

Location

Unknown Facility

Toms River, New Jersey, 08755, United States

Location

Unknown Facility

New Windsor, New York, 12553, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Toledo, Ohio, 43623, United States

Location

Unknown Facility

Plano, Texas, 75075, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 5, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-11

Locations

US (11)