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).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Biological: ISCOMATRIX™; Biological: Placebo to V950; Biological: V950

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 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: ISCOMATRIX™; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.; Biological: V950; V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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).	Month 7
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.	Baseline and Month 7

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): January 1, 2012

Study Registration Dates

• First Submitted: April 20, 2007
• First Submitted That Met QC Criteria: April 20, 2007
• First Posted (ESTIMATE): April 23, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: V950-001; 2007_518 (OTHER: Merck Registration ID)