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Completed

NCT Number: NCT01284387

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

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.

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Key information

Conditions

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

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Janssen AI Investigational Site, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ACC-001 (vanutide cridificar)

Biological

Comparisons of 2 different doses of ACC-001 or placebo for 24 months

Other names: vanutide cridificar

Primary outcomes

  1. To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.

    Time frame: 24 Months

Secondary outcomes

  1. To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD.

    Time frame: 24 Months

    As assessed by:

    • The incidence and severity of treatment-emergent adverse events (TEAEs); and
    • Clinically important changes in safety assessment results (vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], and physical and neurological examinations).

  2. Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.

    Time frame: 24 Months

  3. Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.

    Time frame: 24 Months

  4. Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales.

    Time frame: 24 Months

  5. Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures.

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS-21 Adjuvant in Subjects With Mild to Moderate Alzheimer's Disease

Acronym: ACCTION

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2011
Registry last updated
Jan 5, 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.

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