ACCTION

CompletedPhase 2

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

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

Lead sponsor

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

Asset

ACC-001

Listed sites

Recruiting sites

Enrollment

126

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Effect of ACC-001 in combination

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDACC-001-ALZ-2001

NCT IDNCT01284387

Timeline

Milestones

Study start2011-01 (month precision)

Study first posted2011-01-27estimated

Primary completion2014-01actual (month precision)

Study completion2014-02actual (month precision)

Last update posted2015-01-05estimated

Assets

Drug assets

ACC-001

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age89 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Amyloid biomarkers

Neuroimaging

Safety / tolerability / PK

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

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

descriptive

Neuroimaging

1 endpoint

Secondary/protocol endpoint

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

event count, event

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

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

change from baseline, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Ketter N, Liu E, Di J, Honig LS, Lu M, Novak G, Werth J, LePrince Leterme G, Shadman A, Brashear HR. A Randomized, Double-Blind, Phase 2 Study of the Effects of the Vaccine Vanutide Cridificar with QS-21 Adjuvant on Immunogenicity, Safety and Amyloid Imaging in Patients with Mild to Moderate Alzheimer's Disease. J Prev Alzheimers Dis. 2016;3(4):192-201. doi: 10.14283/jpad.2016.118.
PMID29199321via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.