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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00464334

First received: April 20, 2007

Last updated: September 24, 2015

Last verified: September 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

April 20, 2007

Last Updated Date

September 24, 2015

Start Date ^ICMJE

March 2007

Primary Completion Date

January 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.
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.
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.

Original Primary Outcome Measures ^ICMJE

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Change History

Complete list of historical versions of study NCT00464334 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

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

Study Arms

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.
Interventions:
- Biological: ISCOMATRIX™
- 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.
Interventions:
- Biological: ISCOMATRIX™
- 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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™
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.
Interventions:
- Biological: V950
- Biological: ISCOMATRIX™

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

January 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

55 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

France, Sweden, United States

Administrative Information

NCT Number ^ICMJE

NCT00464334

Other Study ID Numbers ^ICMJE

V950-001
2007_518 ( Other Identifier: Merck Registration ID )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

September 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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