Alzheimer's DiseasePhase 2NCT01227564

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

A Phase 2 study testing ACC-001 3 μg/ QS-21 50 μg and ACC-001 10 μg/ QS-21 50 μg in people with Alzheimer's Disease, run by Pfizer at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans. Read more about this study

Who is it for?: Ages 50 to 80 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: ACC-001 3 μg/ QS-21 50 μg and ACC-001 10 μg/ QS-21 50 μg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 40 sitesUnited States
Study dates: Feb 2011to Feb 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
Mini-Mental State Examination (MMSE) score ≥ 25
Global Clinical Dementia Rating = 0.5.
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
Amyloid burden detected on screening brain PET scan.
Other inclusion criteria apply.

Who cannot join

Significant neurological disease other than early Alzheimer's disease
Major psychiatric disorder or symptom
Contraindication to undergo brain MRI
Unstable medical conditions
Other exclusion criteria apply

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

The Memory Clinic
Bennington, Vermont, 05201
The Pharmacy Inc.
Bennington, Vermont, 05201
Massachusetts General Hospital (For PET only)
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Meridien Research
Brooksville, Florida, 34601
Satatoga PET Associates
Clifton Park, New York, 12065
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, 02914
Memory Enhancement Center of America, Incorporated
Eatontown, New Jersey, 07724
Florida Neurology Group PL
Fort Myers, Florida, 33907
Internal Medicine Associates of Lee County, MD, PA
Fort Myers, Florida, 33912
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Florida Radiology Leasing, Limited Liability Corporation
Fort Myers, Florida, 33919
Radiology Regional Center
Fort Myers, Florida, 33919
Baylor College of Medicine, Department of Neurology
Houston, Texas, 77030
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
Steinberg Diagnostic Imaging
Las Vegas, Nevada, 89128
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Miami Jewish Health Systems
Miami, Florida, 33137
Mount Sinai Medical Center
Miami Beach, Florida, 33140
GCRC (Drug administered)
New Haven, Connecticut, 06510
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven, Connecticut, 06510
Investigational Drug Service
New Haven, Connecticut, 06511
Norman S. Werdiger, MD
New Haven, Connecticut, 06519
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Pacific Neuroscience Medical Group
Oxnard, California, 93030
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Banner Good Samaritan Medical Center
Phoenix, Arizona, 85006
Butler Hospital
Providence, Rhode Island, 02906
Banner Boswell Medical Center
Sun City, Arizona, 85351
Banner Lakes Imaging Center
Sun City, Arizona, 85351
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Southwest PET Institute
Tucson, Arizona, 85719
University of Arizona, Health Sciences Center - Department of Neurology
Tucson, Arizona, 85724-5023
Universal Medical Center
Tucson, Arizona, 85724
Northwest NeuroSpecialists, LLC
Tucson, Arizona, 85741
Radiology Limited
Tucson, Arizona, 85741
Clinical Research Unit
Washington D.C., District of Columbia, 20007
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Georgetown University Medical Center Department of Neurology
Washington D.C., District of Columbia, 20057
Premiere Research Institute (Palm Beach Neurology)
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.

Conditions: Alzheimer's Disease
Being tested: ACC-001 3 μg/ QS-21 50 μg, ACC-001 10 μg/ QS-21 50 μg, Placebo- Phosphate buffered saline (PBS)
Keywords: Early Alzheimer's disease, active immunization, amyloid imaging
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 3 μg/ QS-21 50 μgBiological
Also called Vanutide Cridificar
ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
ACC-001 10 μg/ QS-21 50 μgBiological
Also called Vanutide Cridificar
ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
Placebo- Phosphate buffered saline (PBS)Other
Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18

Study groups in NCT01227564
Study group	Role	What they receive
ACC-001 3 μg/ QS-21 50 μg	Experimental	Not described Receives: Biological: ACC-001 3 μg/ QS-21 50 μg
ACC-001 10 μg/ QS-21 50 μg	Experimental	Not described Receives: Biological: ACC-001 10 μg/ QS-21 50 μg
Placebo- Phosphate buffered saline (PBS)	Placebo comparator	Not described Receives: Other: Placebo- Phosphate buffered saline (PBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.
Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Feb 2014

First posted25 Oct 2010 (estimated)
Study startFeb 2011
Primary completionFeb 2014
Study completionFeb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
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: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01227564
Sponsor's protocol ID: B2571010
Other IDs: B2571010, 3134K1-2208
Status last verified: Jan 2016
First submitted: 22 Oct 2010
Last updated: 25 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.
PubMed 29210443

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.
ClinicalTrials.gov ID: NCT01227564
Acronym / sponsor ID: B2571010
Conditions: Alzheimer's Disease
Keywords: Early Alzheimer's disease, active immunization, amyloid imaging
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Feb 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 25 Oct 2010 (estimated)
Results: Posted 25 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
ACC-001 3 μg/ QS-21 50 μg	Experimental	Biological: ACC-001 3 μg/ QS-21 50 μg
ACC-001 10 μg/ QS-21 50 μg	Experimental	Biological: ACC-001 10 μg/ QS-21 50 μg
Placebo- Phosphate buffered saline (PBS)	Placebo comparator	Other: Placebo- Phosphate buffered saline (PBS)

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Concern about a change in cognition expressed by the subject or by an informant that knows the subject well
Mini-Mental State Examination (MMSE) score ≥ 25
Global Clinical Dementia Rating = 0.5.
General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening.
Amyloid burden detected on screening brain PET scan.

Key exclusion criteria (5 listed)

Significant neurological disease other than early Alzheimer's disease
Major psychiatric disorder or symptom
Contraindication to undergo brain MRI
Unstable medical conditions
Other exclusion criteria apply

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 3 μg/ QS-21 50 μgAlso: Vanutide CridificarACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18	Biological	ACC-001 3 μg/ QS-21 50 μg
ACC-001 10 μg/ QS-21 50 μgAlso: Vanutide CridificarACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18	Biological	ACC-001 10 μg/ QS-21 50 μg
Placebo- Phosphate buffered saline (PBS)Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18	Other	Placebo- Phosphate buffered saline (PBS)

Primary outcome

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)
Time frame: 104 weeks
Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.

Results and safety

Results posted to the registry on 25 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ACC 3 μg+QS-21	22	18
ACC 10 μg+QS-21	20	18
Placebo	21	15

Primary outcome: Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs)

Time frame: 104 weeks. Least squares mean (95% Confidence Interval). Unit: ratio

Measure	ACC 3 μg+QS-21 n = 22	ACC 10 μg+QS-21 n = 20	Overall ACC + QS21 n = 42	Placebo n = 21
Week 52 (N: 22, 19, 41, 20)	0.009 (-0.042 to 0.060)	0.017 (-0.039 to 0.073)	0.013 (-0.025 to 0.051)	0.011 (-0.043 to 0.065)
Week 78 (N: 21, 18, 39, 16)	-0.011 (-0.084 to 0.062)	-0.022 (-0.101 to 0.057)	-0.017 (-0.071 to 0.038)	-0.014 (-0.096 to 0.068)
Week 104 (N: 14, 15, 29, 13)	-0.018 (-0.097 to 0.061)	-0.018 (-0.098 to 0.062)	-0.018 (-0.075 to 0.038)	0.032 (-0.052 to 0.115)

ACC 3 μg+QS-21 vs Placebo: Mean Difference (Final Values): -0.002 (95% CI -0.075 to 0.071), p = 0.9538, Mixed-Effects Model Repeated Measures
ACC 10 μg+QS-21 vs Placebo: Mean Difference (Final Values): 0.006 (95% CI -0.070 to 0.081), p = 0.8787, Mixed-Effects Model Repeated Measures
Overall ACC + QS21 vs Placebo: Mean Difference (Final Values): 0.002 (95% CI -0.062 to 0.066), p = 0.9544, Mixed-Effects Model Repeated Measures

Population analysed: The full analysis set (FAS) population included all randomized participants who had at least one dose of investigational product.

Adverse events

Time frame: From Day 1 throughout the study (104 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACC 3 μg+QS-21	1 of 22 (4.5%)	20 of 22 (90.9%)	Not reported
ACC 10 μg+QS-21	6 of 20 (30%)	19 of 20 (95%)	Not reported
Placebo	6 of 21 (28.6%)	17 of 21 (81%)	Not reported

Limitations and caveats (from the sponsor): In 2013 Pfizer and Janssen Alzheimer Immunotherapy Alliance made the decision that ACC-001 would not be further developed in mild to moderate AD.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29210443van Dyck CH, Sadowsky C, Le Prince Leterme G, Booth K, Peng Y, Marek K, Ketter N, Liu E, Wyman BT, Jackson N, Slomkowski M, Ryan JM. Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Individuals with Early Alzheimer's Disease: Amyloid Imaging Positron Emission Tomography and Safety Results from a Phase 2 Study. J Prev Alzheimers Dis. 2016;3(2):75-84. doi: 10.14283/jpad.2016.91.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

40 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 3 μg/ QS-21 50 μg and ACC-001 10 μg/ QS-21 50 μg in people with Alzheimer's Disease, run by Pfizer at 40 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 6 inclusion and 5 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 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 25 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs) (time frame: 104 weeks). 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 NCT01227564, 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 25 Feb 2016.