A Study of V950 in People With Alzheimer Disease - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00464334

Purpose

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950.

Condition	Intervention	Phase
Alzheimer Disease	Biological: V950 Biological: Comparator: ISCOMATRIX™	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Aluminum

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of V950 Formulated on Aluminum-Containing Adjuvant With or Without ISCOMATRIX™ in Patients With Alzheimer Disease

Further study details as provided by Merck:

Primary Outcome Measures:

General safety and tolerability after each dose and throughout the study [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity after each dose and throughout the study [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	April 2007
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage I: Experimental Stage I: 0.5 ug V950/ 0 ug IMX	Biological: V950 3-dose regimen of 0.5 ml IM injections at 0, 2 and 6 months.
Stage II Stage II: Patients in Panel A will receive 5 ug V950/0 ug IMX (Panel B) or 0.5 ug V950/20 ug IMX (Panel C).	Biological: V950 3-dose regimen of 0.5 ml IM injections at 0, 2 and 6 months. Biological: Comparator: ISCOMATRIX™ 20 ug IMX, 60 ug IMX
Stage III Stage III: Patients from Panel B will receive 50 ug V950/0 ug IMX (Panel D) or 5 ug V950/20 ug IMX (Panel E). Patients from Panel C will receive 5 ug V950/20 ug IMX (Panel E) or 0.5 ug V950/60 ug IMX (Panel X).	Biological: V950 3-dose regimen of 0.5 ml IM injections at 0, 2 and 6 months. Biological: Comparator: ISCOMATRIX™ 20 ug IMX, 60 ug IMX
Stage IV Stage IV: Patients from Panel D will receive 50 ug V950/20 ug IMX (Panel F). Patients from Panel E will receive 50 ug V950/ 20 ug IMX (Panel F) or 5 ug V950/60 ug IMX (Panel G). Patients from Panel X will receive 5 ug V950/60 ug IMX (Panel G). All patients from Panels F and G will receive 50 ug V950/60 ug IMX (Panel Y).	Biological: V950 3-dose regimen of 0.5 ml IM injections at 0, 2 and 6 months. Biological: Comparator: ISCOMATRIX™ 20 ug IMX, 60 ug IMX

Eligibility

Criteria

Inclusion Criteria:

Patient has mild to moderate Alzheimer Disease
Women cannot be able to get pregnant
Patient has a reliable caregiver, who will attend all visits and answer questions about the patient

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464334

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Arizona
Call for Information	Recruiting
Phoenix, Arizona, United States, 85006
Call for Information	Recruiting
Litchfield Park, Arizona, United States, 85340
United States, District of Columbia
Call for Information	Recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
Call for Information	Recruiting
Palm Beach Gardens, Florida, United States, 33418
United States, Georgia
Call for Information	Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Call for Information	Recruiting
Chicago, Illinois, United States, 60612
United States, Maryland
Call for Information	Recruiting
Baltimore, Maryland, United States, 21205
France
Laboratoires Merck Sharp & Dohme - Chibret	Recruiting
Paris Cedex 8, France, 75114
Contact: Jean-Marie Goehrs 33-1-4754-89-90
Sweden
Merck Sharp & Dohme (Sweden) AB	Recruiting
Sollentuna, Sweden, 192 07
Contact: Roger Juhlin 46-8-626-1 458

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_518, V950-001
Study First Received:	April 20, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00464334
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 16, 2009