Alzheimer DiseasePhase 2NCT00960531

A Long Term Extension Study Evaluating ACC-001 With QS-21 in Subjects With Mild to Moderate Alzheimer's Disease

A Phase 2 study testing ACC-001+ QS21 (3mcg), ACC-001 (10 mcg) + QS-21 and ACC-001+QS-21 (30mcg) in people with Alzheimer Disease, run by Pfizer at 28 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease. Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Alzheimer Disease
What is being tested?: ACC-001+ QS21 (3mcg), ACC-001 (10 mcg) + QS-21 and ACC-001+QS-21 (30mcg)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 28 sitesUnited States
Study dates: Jul 2009to Dec 2013
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
Mini-Mental State Examination (MMSE) score greater than or equal to 10.
Other criteria apply.

Who cannot join

Significant Neurological Disease other than Alzheimer's disease.
Current clinically significant systemic illness.
Other exclusion criteria apply.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Southwestern Vermont Healthcare
Bennington, Vermont, 05201
The Memory Clinic
Bennington, Vermont, 05201
The Pharmacy, Inc
Bennington, Vermont, 05201
Brigham and Woman's Hospital
Boston, Massachusetts, 02115
Center for Alzheimer Research and Treatment
Boston, Massachusetts, 02115
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
MD Clinical
Hallandale, Florida, 33009
Yale New Haven Hospital
New Haven, Connecticut, 06510
Yale University School of Medicine
New Haven, Connecticut, 06510
Yale-New Haven Hospital
New Haven, Connecticut, 06511
Columbia University/Taub Institute
New York, New York, 10032
CUMC Research Pharmacy
New York, New York, 10032
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Butler Hospital
Providence, Rhode Island, 02906
University of California San Francisco
San Francisco, California, 94117
University of California, San Francisco
San Francisco, California, 94117
University of California - San Francisco
San Francisco, California, 94143
University of California San Francisco
San Francisco, California, 94158
University of California, San Francisco
San Francisco, California, 94158
Barnes Jewish Hospital
St Louis, Missouri, 63108
Washington University School of Medicine
St Louis, Missouri, 63108
Barnes Jewish Hospital at Washington University
St Louis, Missouri, 63110
Washington University School of Medicine
St Louis, Missouri, 63110
Banner Boswell Medical Center
Sun City, Arizona, 85351
Banner Sun Health Research Institute
Sun City, Arizona, 85351
General Clinical Research Unit
Washington D.C., District of Columbia, 20007
Georgetown University Medical Center
Washington D.C., District of Columbia, 20057
Palm Beach Neurology - Premiere Research Institute
West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

Conditions: Alzheimer Disease
Being tested: ACC-001+ QS21 (3mcg), ACC-001 (10 mcg) + QS-21, ACC-001+QS-21 (30mcg)
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+ QS21 (3mcg)Biological
ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001 (10 mcg) + QS-21Biological
ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo
ACC-001+QS-21 (30mcg)Biological
ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo

Study groups in NCT00960531
Study group	Role	What they receive
ACC-001 (3mcg) + QS-21	Experimental	ACC-001 (3mcg) + QS-21 Receives: Biological: ACC-001+ QS21 (3mcg)
ACC-001 (10mcg) + QS-21	Experimental	ACC-001 (10mcg) + QS-21 Receives: Biological: ACC-001 (10 mcg) + QS-21
ACC-001 (30mcg) + QS-21	Experimental	ACC-001 (30mcg) + QS-21 Receives: Biological: ACC-001+QS-21 (30mcg)

What is being measured

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

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: 24 months

Timeline

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

Jul 2009Dec 2013

First posted17 Aug 2009 (estimated)
Study startJul 2009
Primary completionDec 2013
Study completionDec 2013

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.
Other trials for Alzheimer 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: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00960531
Sponsor's protocol ID: 3134K1-2205
Other IDs: B2571008
Status last verified: Mar 2016
First submitted: 13 Aug 2009
Last updated: 1 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Multicenter, Randomized, Third-party Un-blinded, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimer Disease
ClinicalTrials.gov ID: NCT00960531
Acronym / sponsor ID: 3134K1-2205
Conditions: Alzheimer Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 160 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Jul 2009
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 17 Aug 2009 (estimated)
Results: Posted 1 Apr 2016

Clinical summary

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

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, plus QS-21 in subjects with mild to moderate Alzheimer's disease.

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 (3mcg) + QS-21	Experimental	Biological: ACC-001+ QS21 (3mcg)ACC-001 (3mcg) + QS-21
ACC-001 (10mcg) + QS-21	Experimental	Biological: ACC-001 (10 mcg) + QS-21ACC-001 (10mcg) + QS-21
ACC-001 (30mcg) + QS-21	Experimental	Biological: ACC-001+QS-21 (30mcg)ACC-001 (30mcg) + QS-21

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects randomized under previous 3134K1-2201 study (NCT00498602) and met all inclusion/and none of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
Mini-Mental State Examination (MMSE) score greater than or equal to 10.
Other criteria apply.

Key exclusion criteria (3 listed)

Significant Neurological Disease other than Alzheimer's disease.
Current clinically significant systemic illness.
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+ QS21 (3mcg)ACC-001 3mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo	Biological	ACC-001 (3mcg) + QS-21
ACC-001 (10 mcg) + QS-21ACC-001 10mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo	Biological	ACC-001 (10mcg) + QS-21
ACC-001+QS-21 (30mcg)ACC-001 30mcg + QS-21 50 mcg Intra-muscular (IM) q 6 mo	Biological	ACC-001 (30mcg) + QS-21

Primary outcome

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Time frame: 24 months
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Results and safety

Results posted to the registry on 1 Apr 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 / ACC 3 µg+QS-21	21	11
QS-21 / ACC 3 µg+QS-21	6	5
ACC 10 µg+QS-21 / ACC 10 µg+QS-21	41	15
ACC 10 µg / ACC 10 µg+QS-21	25	17
QS-21 / ACC 10 µg+QS-21	5	3
PBS / ACC 10 µg+QS-21	9	6
ACC 30 µg+QS-21 / ACC 30 µg+QS-21	27	3
ACC 30 µg / ACC 30 µg+QS-21	6	2
QS-21 / ACC 30 µg+QS-21	16	2
PBS / ACC 30 μg+QS-21	4	3

Primary outcome: Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)

Time frame: 24 months. Number. Unit: percentage of participants

Measure	ACC 3 µg+QS-21 / ACC 3 µg+QS-21 n = 21	QS-21 / ACC 3 µg+QS-21 n = 6	Active / ACC 10 µg+QS-21 n = 65	Control / ACC 10 µg+QS-21 n = 14	Active / ACC 30 µg+QS-21 n = 33	Control / ACC 30 μg+QS-21 n = 20
Percentage of participants with AEs	100.0	100.0	93.8	92.9	78.8	90.0
Percentage of participants with SAEs	28.6	0.0	24.6	14.3	12.1	20.0

Population analysed: All participants who received at least one dose of the study drug were included in the safety population. For safety analyses, the participants were summarized according to the combination of treatments they actually received during the 3134K1-200-EU or 3134K1-2201-US lead-in studies and 3134K1-2203-EU or 3134K1-2205-US extension studies.

Adverse events

Time frame: Approximately 24 months, starting from Day 1, inclusive 18 months of dosing and 6 months of follow-up after the last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACC 3 µg+QS-21 / ACC 3 µg+QS-21	6 of 21 (28.6%)	19 of 21 (90.5%)	Not reported
QS-21 / ACC 3 µg+QS-21	0 of 6 (0%)	6 of 6 (100%)	Not reported
Active / ACC 10 µg+QS-21	16 of 65 (24.6%)	55 of 65 (84.6%)	Not reported
Control / ACC 10µg+QS-21	2 of 14 (14.3%)	13 of 14 (92.9%)	Not reported
Active / ACC 30 µg+QS-21	4 of 33 (12.1%)	23 of 33 (69.7%)	Not reported
Control / ACC 30 μg+QS-21	4 of 20 (20%)	17 of 20 (85%)	Not reported

Limitations and caveats (from the sponsor): In 2013 the sponsor decided that ACC-001 would not be further developed in mild to moderate Alzheimer's disease, study drug administration was discontinued, and remaining participants were followed for safety for up to 6 months after last injection.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

28 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+ QS21 (3mcg), ACC-001 (10 mcg) + QS-21 and ACC-001+QS-21 (30mcg) in people with Alzheimer Disease, run by Pfizer at 28 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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?

Yes. Results are posted in the registry (first posted 1 Apr 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?

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs) (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 NCT00960531.

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 1 Apr 2016.