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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

Placebo to V950

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

Placebo to V950

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

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.

Group Type EXPERIMENTAL

V950

Intervention Type BIOLOGICAL

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

ISCOMATRIX™

Intervention Type BIOLOGICAL

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

Interventions

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V950

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

Intervention Type BIOLOGICAL

ISCOMATRIX™

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

Intervention Type BIOLOGICAL

Placebo to V950

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No