A Study of V950 in People With Alzheimer Disease (V950-001 AM7) - Full Text View

Purpose

The purpose of this study is to test the safety, tolerability and the immune response to an investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).

Condition	Intervention	Phase
Alzheimer Disease	Biological: V950 Biological: ISCOMATRIX™ Biological: Placebo to V950	Phase 1

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:

Number of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 4 years after first dose of vaccine ] [ Designated as safety issue: Yes ]
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 6 months after first dose of vaccine ] [ Designated as safety issue: Yes ]
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7 [ Time Frame: Month 7 ] [ Designated as safety issue: No ]
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies [ Time Frame: Baseline and Month 7 ] [ Designated as safety issue: No ]
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.

Enrollment:	86
Study Start Date:	March 2007
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Placebo to V950/IMX 0 mcg Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment. Biological: Placebo to V950
Experimental: Placebo to V950/IMX 16 mcg Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment. Biological: Placebo to V950
Experimental: V950 0.5 mcg/IMX 0 mcg Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 0.5 mcg/IMX 16 mcg Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 0.5 mcg/IMX 47 mcg Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 0.5 mcg/IMX 94 mcg Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 5 mcg/IMX 0 mcg Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 5 mcg/IMX 16 mcg Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 5 mcg/IMX 47 mcg Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 50 mcg/IMX 0 mcg Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Experimental: V950 50 mcg/IMX 16 mcg Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.	Biological: V950 V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. Biological: ISCOMATRIX™ ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.

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:	V950-001, 2007_518
Study First Received:	April 20, 2007
Results First Received:	November 19, 2012
Last Updated:	November 19, 2012
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 May 19, 2013