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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease

Treatments: Biological: ISCOMATRIX™; Biological: Placebo to V950; Biological: V950

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464334

2007_518 (Other Identifier)

V950-001

Details and patient eligibility

About

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).

Enrollment: 86 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 11 patient groups

Placebo to V950/IMX 0 mcg

Experimental group

Description:

Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: Placebo to V950

Biological: ISCOMATRIX™

Placebo to V950/IMX 16 mcg

Experimental group

Description:

Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: Placebo to V950

Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 0 mcg

Experimental group

Description:

Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 16 mcg

Experimental group

Description:

Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 47 mcg

Experimental group

Description:

Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 0.5 mcg/IMX 94 mcg

Experimental group

Description:

Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 5 mcg/IMX 0 mcg

Experimental group

Description:

Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 5 mcg/IMX 16 mcg

Experimental group

Description:

Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 5 mcg/IMX 47 mcg

Experimental group

Description:

Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 50 mcg/IMX 0 mcg

Experimental group

Description:

Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™

V950 50 mcg/IMX 16 mcg

Experimental group

Description:

Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6.

Treatment:

Biological: V950

Biological: ISCOMATRIX™