Alzheimer's DiseasePhase 2ACCTIONNCT01284387
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing ACC-001 (vanutide cridificar) in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ACC-001 (vanutide cridificar)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 25 sitesUnited States
- Study dates
- Jan 2011to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Janssen AI Investigational Site
Albany, New York, 12205
Janssen AI Investigational Site
Boston, Massachusetts, 02115
Janssen AI Investigational Site
Centerville, Ohio, 45459
Janssen AI Investigational Site
Kansas City, Missouri, 64111
Janssen AI Investigational Site
La Jolla, California, 92093
Janssen AI Investigational Site
Las Vegas, Nevada, 89106
Janssen AI Investigational Site
Long Beach, California, 90806
Janssen AI Investigational Site
Los Angeles, California, 90095
Janssen AI Investigational Site
Miami, Florida, 33137
Janssen AI Investigational Site
Miami, Florida, 33410
Janssen AI Investigational Site
New York, New York, 10032
Janssen AI Investigational Site
Ocala, Florida, 34471
Janssen AI Investigational Site
Oklahoma City, Oklahoma, 73112
Janssen AI Investigational Site
Orlando, Florida, 32806
Janssen AI Investigational Site
Oxnard, California, 93030
Janssen AI Investigational Site
Princeton, New Jersey, 08540
Janssen AI Investigational Site
San Diego, California, 92103
Janssen AI Investigational Site
San Francisco, California, 94143
Janssen AI Investigational Site
Scarborough, Maine, 04074
Janssen AI Investigational Site
Sun City, Arizona, 33613
Janssen AI Investigational Site
Sunrise, Florida, 33351
Janssen AI Investigational Site
Tampa, Florida, 33609
Janssen AI Investigational Site
Tampa, Florida, 33617
Janssen AI Investigational Site
Washington D.C., District of Columbia, 20057
Janssen AI Investigational Site
West Palm Beach, Florida, 33407
About this study
Official 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
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.
- Conditions
- Alzheimer's Disease
- Being tested
- ACC-001 (vanutide cridificar)
- Keywords
- Mild to moderate Alzheimer's disease, immunization, amyloid imaging, injection, vaccine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACC-001 (vanutide cridificar)Biological
Also called vanutide cridificar
Comparisons of 2 different doses of ACC-001 or placebo for 24 months
| Study group | Role | What they receive |
|---|---|---|
| 3 μg ACC-001 / QS-21 50 μg IM dose 1 | Experimental | 3 μg ACC-001 / QS-21 50 μg IM Receives: 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 Receives: Biological: ACC-001 (vanutide cridificar) |
| Placebo - Phosphate buffered saline (PBS) IM dose | No intervention | Placebo - Phosphate buffered saline (PBS) IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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).
Measured: 24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284387
- Sponsor's protocol ID
- ACC-001-ALZ-2001
- Acronym
- ACCTION
- Status last verified
- Dec 2014
- First submitted
- 20 Jan 2011
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29199321
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT01284387
- Acronym / sponsor ID
- ACCTION / ACC-001-ALZ-2001
- Conditions
- Alzheimer's Disease
- Keywords
- Mild to moderate Alzheimer's disease, immunization, amyloid imaging, injection, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 27 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 μg ACC-001 / QS-21 50 μg IM dose 1 | Experimental | Biological: ACC-001 (vanutide cridificar)3 μg ACC-001 / QS-21 50 μg IM |
| 10 μg ACC-001 / QS-21 50 μg IM dose 2 | Experimental | Biological: ACC-001 (vanutide cridificar)10 μg ACC-001 / QS-21 50 μg IM |
| Placebo - Phosphate buffered saline (PBS) IM dose | No intervention | –Placebo - Phosphate buffered saline (PBS) IM |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACC-001 (vanutide cridificar)Also: vanutide cridificarComparisons of 2 different doses of ACC-001 or placebo for 24 months | Biological | 10 μg ACC-001 / QS-21 50 μg IM dose 2, 3 μg ACC-001 / QS-21 50 μg IM dose 1 |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Derived from this study: PubMed 29199321Ketter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ACC-001 (vanutide cridificar) in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.