NCT01284387|CompletedPhase 2DMC

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

ACCTION

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

JANSSEN Alzheimer Immunotherapy Research & Development, LLC ClinicalTrials.gov

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1 other identifier

ACC-001-ALZ-2001

Study Type

interventional

Target

126

Locations

1 country

Sites

Timeline

RegisteredJan 2011

StartedJan 2011

CompletionFeb 2014

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

126

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2011

Typical duration for phase_2

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

January 1, 2011

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed

7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed

Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

January 20, 2011

Last Update Submit

December 11, 2014

Conditions

Alzheimer's Disease

Keywords

Mild to moderate Alzheimer's diseaseimmunizationamyloid imaginginjectionvaccine

Outcome Measures

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.
24 Months

Secondary Outcomes (5)

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.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures.
24 Months

Study Arms (3)

3 μg ACC-001 / QS-21 50 μg IM dose 1

EXPERIMENTAL

3 μg ACC-001 / QS-21 50 μg IM

Biological: ACC-001 (vanutide cridificar)

10 μg ACC-001 / QS-21 50 μg IM dose 2

EXPERIMENTAL

10 μg ACC-001 / QS-21 50 μg IM

Biological: ACC-001 (vanutide cridificar)

Placebo - Phosphate buffered saline (PBS) IM dose

NO INTERVENTION

Placebo - Phosphate buffered saline (PBS) IM

Interventions

ACC-001 (vanutide cridificar)BIOLOGICAL

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

Also known as: vanutide cridificar

10 μg ACC-001 / QS-21 50 μg IM dose 23 μg ACC-001 / QS-21 50 μg IM dose 1

Eligibility Criteria

Age50 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.