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

Merck Sharp & Dohme LLC86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

V950BIOLOGICAL

V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.

ISCOMATRIX™BIOLOGICAL

ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.

Placebo to V950BIOLOGICAL

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

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

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.

Time frame: 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).

Time frame: 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.

Time frame: Baseline and Month 7

Data from ClinicalTrials.gov

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