Skip to main content
OpenTrials
Completed

NCT Number: NCT00464334

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V950

Biological

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 V950

Biological

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Apr 23, 2007
Registry last updated
Sep 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.