Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease (ACCTION)

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Alzheimer's Disease

Treatments: Biological: ACC-001 (vanutide cridificar)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01284387

ACC-001-ALZ-2001

Details and patient eligibility

About

A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.

Enrollment: 126 patients

Sex: All

Ages: 50 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of probable AD
• Age from 50 to 89
• Mini-Mental Status Exam score of 18-26 inclusive
• Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
• Stable doses of medications (cholinesterase inhibitors and memantine allowed)
• Caregiver able to attend all clinic visits with patient
• Amyloid burden on screening PET scan consistent with diagnosis of AD

Exclusion criteria

• Significant neurological disease other than AD
• Major psychiatric disorder
• Significant systemic illness
• History of stroke, seizure or autoimmune disease
• History of myocardial infarction within the last 2 years
• Smoking greater than 20 cigarettes per day
• Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed)
• Prior treatment experimental immunotherapeutics or vaccines for AD
• Women of childbearing potential
• Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 3 patient groups

3 μg ACC-001 / QS-21 50 μg IM dose 1

Experimental group

Description:

3 μg ACC-001 / QS-21 50 μg IM

Treatment:

Biological: ACC-001 (vanutide cridificar)

10 μg ACC-001 / QS-21 50 μg IM dose 2

Experimental group

Description:

10 μg ACC-001 / QS-21 50 μg IM

Treatment:

Biological: ACC-001 (vanutide cridificar)

Placebo - Phosphate buffered saline (PBS) IM dose

No Intervention group

Description:

Placebo - Phosphate buffered saline (PBS) IM