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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464334
• Other study ID #: V950-001
• Secondary ID: 2007_518
• Status: Completed
• Phase: Phase 1
• First received: April 20, 2007
• Last updated: September 24, 2015
• Start date: March 2007
• Est. completion date: January 2012

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Biological:
• V950
V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.
• ISCOMATRIX™
ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
• Placebo to V950

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 4 years after first dose of vaccine	Yes
Primary	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.	Up to 6 months after first dose of vaccine	Yes
Primary	Geometric Mean Titer (GMT) of Amyloid Beta (Aß) Peptide 1-40 Specific Antibodies at Month 7	The level of Aß 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).	Month 7	No
Primary	Mean Fold Change From Baseline in GMT of Aß Peptide 1-40 Specific Antibodies	The Aß 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 Aß 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.	Baseline and Month 7	No