Alzheimer DiseasePhase 2NCT00498602

Study Evaluating ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

A Phase 2 study testing ACC-001 + QS-21, QS-21 and Diluent: Phosphate Buffered Saline in people with Alzheimer Disease, run by Pfizer at 27 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

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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 + QS-21, QS-21 and Diluent: Phosphate Buffered Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 27 sitesUnited States
Study dates: Nov 2007to Feb 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

Diagnosis of mild to moderate Alzheimer's disease
Age 50-85
Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Who cannot join

Significant Neurological Disease
Major psychiatric disorder
Clinically significant systemic illness Other exclusion criteria apply.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

The Memory Clinic
Bennington, Vermont, 05201
The Pharmacy
Bennington, Vermont, 05201
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724
Pharmcare USA
Edison, New Jersey, 08837
MD Clinical
Hallandale, Florida, 33009
General Clinical Research Center
New Haven, Connecticut, 06509
Yale University School of Medicine
New Haven, Connecticut, 06510
Yale-New Haven Hospital
New Haven, Connecticut, 06511
Columbia Univ/Taub Institute Irving Ctr for Clinical Researc
New York, New York, 10032
CUMC Research Pharmacy
New York, New York, 10032
Banner Alzheimer's Institute
Phoenix, Arizona, 85006
Banner Good Samaritan Medical Center
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, 94118
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
Barrnes-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
Sun Health Research Institute
Sun City, Arizona, 85351
General Clinical Research Center
Washington D.C., District of Columbia, 20007
GUMC
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: Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimers Disease

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in subjects with mild to moderate Alzheimer's disease.

Conditions: Alzheimer Disease
Being tested: ACC-001 + QS-21, QS-21, Diluent: Phosphate Buffered Saline, ACC-001
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 + QS-21Biological
IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52
QS-21Biological
IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52
Diluent: Phosphate Buffered SalineOther
IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52
ACC-001Biological
IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52

Study groups in NCT00498602
Study group	Role	What they receive
1	Experimental	ACC-001 Receives: Biological: ACC-001 + QS-21
2	Other	QS-21 Receives: Biological: QS-21
3	Other	Diluent: Phosphate Buffered Saline Receives: Other: Diluent: Phosphate Buffered Saline
4	Experimental	ACC-001 Receives: Biological: ACC-001

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: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose

Secondary outcomes (3)

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.
Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.
Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
IgG subtypes were not assessed
Measured: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Timeline

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

Nov 2007Feb 2013

First posted10 Jul 2007 (estimated)
Study startNov 2007
Primary completionFeb 2013
Study completionFeb 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.
Publications (1)Papers the sponsor has linked to this study.
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: NCT00498602
Sponsor's protocol ID: 3134K1-2201
Other IDs: B2571005
Status last verified: Nov 2015
First submitted: 9 Jul 2007
Last updated: 1 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
PubMed 26967206

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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Study at a glance

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

Official title: Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Mild To Moderate Alzheimers Disease
ClinicalTrials.gov ID: NCT00498602
Acronym / sponsor ID: 3134K1-2201
Conditions: Alzheimer Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Nov 2007
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 10 Jul 2007 (estimated)
Results: Posted 1 Jan 2016

Clinical summary

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

To access the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, 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: 4

Arm	Type	Receives
1	Experimental	Biological: ACC-001 + QS-21ACC-001
2	Other	Biological: QS-21QS-21
3	Other	Other: Diluent: Phosphate Buffered SalineDiluent: Phosphate Buffered Saline
4	Experimental	Biological: ACC-001ACC-001

Who may qualify

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

Key inclusion criteria (3 listed)

Diagnosis of mild to moderate Alzheimer's disease
Age 50-85
Mini Mental State Examination (MMSE) 16-26 Other criteria apply

Key exclusion criteria (3 listed)

Significant Neurological Disease
Major psychiatric disorder
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 + QS-21IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52	Biological	1
QS-21IM injection, QS-21 (50 ug) at Day 1 and weeks 4, 12, 26, and 52	Biological	2
Diluent: Phosphate Buffered SalineIM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52	Other	3
ACC-001IM injection, ACC 001 (10 ug, 30ug) at Day 1 and weeks 4, 12, 26, and 52	Biological	4

Primary outcome

Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
Time frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose
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.

3 secondary outcomes

Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104
Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)
Time frame: Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104

Results and safety

Results posted to the registry on 1 Jan 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	36	26
ACC 10 μg+QS-21	61	51
ACC 30 μg+QS-21	40	32
ACC 10 μg	35	30
ACC 30 μg	12	8
QS-21 Alone	44	31
Phosphate Buffered Saline	17	15

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

Time frame: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose. Number. Unit: percentage of participants

Measure	ACC 3 μg+QS-21 n = 36	ACC 10 μg+QS-21 n = 60	ACC 30 μg+QS-21 n = 40	ACC 10 μg n = 35	ACC 30 μg n = 12	QS-21 Alone n = 44	Phosphate Buffered Saline n = 17
Percentage of participants with AEs	97.2	93.3	90.0	91.4	83.3	90.9	100
Percentage of participants with SAEs	16.7	18.3	17.5	14.3	41.7	11.4	17.6

Population analysed: The safety population included all randomized participants with documented use of at least one dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for 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	6 of 36 (16.7%)	34 of 36 (94.4%)	Not reported
ACC 10 μg+QS-21	11 of 60 (18.3%)	48 of 60 (80%)	Not reported
ACC 30 μg+QS-21	7 of 40 (17.5%)	35 of 40 (87.5%)	Not reported
ACC 10 μg	5 of 35 (14.3%)	28 of 35 (80%)	Not reported
ACC 30 μg	5 of 12 (41.7%)	10 of 12 (83.3%)	Not reported
QS-21 Alone	5 of 44 (11.4%)	40 of 44 (90.9%)	Not reported
Phosphate Buffered Saline	3 of 17 (17.6%)	17 of 17 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26967206Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376.
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

27 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 + QS-21, QS-21 and Diluent: Phosphate Buffered Saline in people with Alzheimer Disease, run by Pfizer at 27 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 3 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: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 Jan 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: approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose). 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 NCT00498602, 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 1 Jan 2016.