A Study of V950 in People With Alzheimer Disease (V950-001) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
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:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Stage I 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. Other Name: V950 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.
Experimental: Stage II 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. Other Name: V950 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.
Experimental: Stage III 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. Other Name: V950 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.
Experimental: Stage IV 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. Other Name: V950 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.
Experimental: Stage V 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. Other Name: V950 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.
Experimental: Stage VI 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. Other Name: V950 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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00464334 History of Changes
Other Study ID Numbers:	2007_518, V950-001
Study First Received:	April 20, 2007
Last Updated:	November 11, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012