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

Sponsor:	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: Comparator: V950/Iscomatrix Biological: Comparator: Placebo	Phase I

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

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:	124
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Stage I: Experimental Panel A: 0.5 ug V950 / 0 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.
Stage II: Experimental Panel B: 5 ug V950 / 0 ug Iscomatrix Panel C: 0.5 ug V950 / 16 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.
Stage III: Experimental Panel D: 50 ug V950 / 0 ug Iscomatrix Panel E: 5 ug V950 / 16 ug Iscomatrix Panel X: 0.5 ug V950 / 47 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.
Stage IV: Experimental Panel F: 50 ug V950 / 16 ug Iscomatrix Panel G: 5 ug V950 / 47 ug Iscomatrix Panel H: 0.5 ug V950 / 94 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.
Stage V: Experimental Panel Y: 50 ug V950 / 47 ug Iscomatrix Panel Z: 5 ug V950 / 94 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.
Stage VI: Experimental Panel AA: 50 ug V950 / 94 ug Iscomatrix	Biological: Comparator: V950/Iscomatrix 0.5 mL V950/Iscomatrix intramuscularly at 0, 2 and 6 months. Three doses of V950/Iscomatrix will be tested; dose escalation will proceed over six stages. V950 will be given in doses of 0.5, 5 or 50 ug. Iscomatrix will be given in doses of 0, 16, 47 or 94 ug. Biological: Comparator: Placebo Placebo 0.5 mL intramuscular injection. Two patients in each panel will receive placebo to V950, which contains either 0 or 16 ug Iscomatrix.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

Patient lives in a nursing home or facility Patient has another neurological or neurodegenerative disorder Patient has a history of stroke Patient uses illicit drugs or has a history of drug/alcohol abuse Patient has received blood or blood derived products within 6 months

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
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Litchfield Park, Arizona, United States, 85340
United States, District of Columbia
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Washington, District of Columbia, United States, 20057
United States, Florida
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Delray Beach, Florida, United States, 33445
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Hallandale Beach, Florida, United States, 33009
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Palm Beach Gardens, Florida, United States, 33418
United States, Georgia
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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, 21224
United States, New Jersey
Call for Information	Recruiting
New Brunswick, New Jersey, United States, 08903-0019
United States, Pennsylvania
Call for Information	Recruiting
Philadelphia, Pennsylvania, United States, 19107
United States, Virginia
Call for Information	Recruiting
Alexandria, Virginia, United States, 22304

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_518
Study First Received:	April 20, 2007
Last Updated:	November 5, 2009
ClinicalTrials.gov Identifier:	NCT00464334 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

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

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 20, 2009