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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Alzheimer Disease
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 86
- Primary Endpoint
- Number of Participants Who Experienced at Least One Adverse Event
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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).
Investigators
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
Outcomes
Primary Outcomes
Number of Participants Who Experienced at Least One Adverse Event
Time Frame: Up to 4 years after first dose of vaccine
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
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
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.
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 6 months after first dose of vaccine
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.