Back to resultsA Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
V950
ISCOMATRIX™
Placebo to V950
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer Disease
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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo to V950/IMX 0 mcg
Placebo to V950/IMX 16 mcg
V950 0.5 mcg/IMX 0 mcg
V950 0.5 mcg/IMX 16 mcg
V950 0.5 mcg/IMX 47 mcg
V950 0.5 mcg/IMX 94 mcg
V950 5 mcg/IMX 0 mcg
V950 5 mcg/IMX 16 mcg
V950 5 mcg/IMX 47 mcg
V950 50 mcg/IMX 0 mcg
V950 50 mcg/IMX 16 mcg
Arm Description
Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Outcomes
Primary Outcome Measures
Number of Participants Who Experienced at Least One 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.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00464334
First Posted
April 20, 2007
Last Updated
September 24, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00464334
Brief Title
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo to V950/IMX 0 mcg
Arm Type
Experimental
Arm Description
Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
Placebo to V950/IMX 16 mcg
Arm Type
Experimental
Arm Description
Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 0.5 mcg/IMX 0 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 0.5 mcg/IMX 16 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 0.5 mcg/IMX 47 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 0.5 mcg/IMX 94 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 5 mcg/IMX 0 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 5 mcg/IMX 16 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 5 mcg/IMX 47 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 50 mcg/IMX 0 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Arm Title
V950 50 mcg/IMX 16 mcg
Arm Type
Experimental
Arm Description
Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.
Intervention Type
Biological
Intervention Name(s)
V950
Intervention Description
V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
Intervention Type
Biological
Intervention Name(s)
ISCOMATRIX™
Intervention Description
ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Intervention Type
Biological
Intervention Name(s)
Placebo to V950
Primary Outcome Measure Information:
Title
Number of Participants Who Experienced at Least One Adverse Event
Description
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.
Time Frame
Up to 4 years after first dose of vaccine
Title
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Description
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.
Time Frame
Up to 6 months after first dose of vaccine
Title
Geometric Mean Titer (GMT) of Amyloid Beta (Aβ) Peptide 1-40 Specific Antibodies at Month 7
Description
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).
Time Frame
Month 7
Title
Mean Fold Change From Baseline in GMT of Aβ Peptide 1-40 Specific Antibodies
Description
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.
Time Frame
Baseline and Month 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
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