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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00464334
First received: April 20, 2007
Last updated: October 22, 2013
Last verified: October 2013

April 20, 2007
October 22, 2013
March 2007
January 2012   (final data collection date for primary outcome measure)
  • 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.
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Complete list of historical versions of study NCT00464334 on ClinicalTrials.gov Archive Site
Not Provided
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Not Provided
Not Provided
 
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
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

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).

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Alzheimer Disease
  • 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.
  • Biological: Placebo to V950
  • 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.
    Interventions:
    • Biological: ISCOMATRIX™
    • 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.
    Interventions:
    • Biological: ISCOMATRIX™
    • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
  • 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.
    Interventions:
    • Biological: V950
    • Biological: ISCOMATRIX™
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00464334
V950-001, 2007_518
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP