Alzheimer DiseasePhase 2NCT00955409

Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease

A Phase 2 study testing ACC-001(3µg) + QS21, ACC-001(10µg) + QS21 and ACC-001(30µg) + QS21 in people with Alzheimer Disease, run by Pfizer at 17 sites in 3 countries.

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

The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, 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(3µg) + QS21, ACC-001(10µg) + QS21 and ACC-001(30µg) + QS21
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 17 sitesin 3 countries
Study dates: 5 Nov 2009to 17 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 3134K1-200 study (NCT00479557) 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 ≥10

Who cannot join

Significant Neurological Disease other than Alzheimer's disease
Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
Clinically significant systemic illness

Trial locations and contacts

17 sites in 3 countries.

Country

City, postcode or hospital

17 sites in 3 countries

France8 sites

CMRR Bordeaux CHU Pellegrin
Bordeaux, 33076
Hopital Roger Salengro
Lille, 59037
Hôpital Roger Salengro
Lille, 59037
CHU La Timone
Marseille, 13385
Groupe Hospitalier Broca-La Rochefoucauld
Paris, 75013
Groupe Hospitalier Pitie-Salpetriere
Paris, 75651 Cedex 13
Hôpital Pitié-Salpétrière
Paris, 75651
Hôpital La Grave
Toulouse, 31059

Other trials in France

Germany6 sites

Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin, 14050
Universitatsklinikum und Poliklinik der Uni Bonn
Bonn, 48129
Klinikum der Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, 79106
Klinik fuer Psychiatrie und Psychotherapie
Göttingen, 37075
Zentralinstitut fuer Seelische Gesundheit Mannheim
Mannheim, 68072
Technische Universität München
Munich, 81675

Other trials in Germany

Spain3 sites

Hospital del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Clinico y Provincial
Barcelona, 08036

Other trials in Spain

About this study

Official title: A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE

Conditions: Alzheimer Disease
Being tested: ACC-001(3µg) + QS21, ACC-001(10µg) + QS21, ACC-001(30µg) + QS21
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(3µg) + QS21Biological
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(10µg) + QS21Biological
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
ACC-001(30µg) + QS21Biological
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18

Study groups in NCT00955409
Study group	Role	What they receive
ACC-001(3µg) + QS21	Experimental	ACC-001(3µg) + QS21 Receives: Biological: ACC-001(3µg) + QS21
ACC-001(10µg) + QS21	Experimental	ACC-001(10µg) + QS21 Receives: Biological: ACC-001(10µg) + QS21
ACC-001(30µg) + QS21	Experimental	ACC-001(30µg) + QS21 Receives: Biological: ACC-001(30µg) + QS21

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.

5 Nov 200917 Dec 2013

First posted10 Aug 2009 (estimated)
Study start5 Nov 2009
Primary completion17 Dec 2013
Study completion17 Dec 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: NCT00955409
Sponsor's protocol ID: 3134K1-2203
Other IDs: B2571007, 2009-010922-21, 2009
Status last verified: Mar 2021
First submitted: 4 Aug 2009
Last updated: 25 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

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 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE IIA, MULTICENTER, RANDOMIZED, THIRD-PARTY UNBLINDED, LONG -TERM EXTENSION STUDY TO DETERMINE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF ACC-001 WITH QS-21 ADJUVANT IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
ClinicalTrials.gov ID: NCT00955409
Acronym / sponsor ID: 3134K1-2203
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: 5 Nov 2009 (actual)
Primary completion: 17 Dec 2013 (actual)
Study completion: 17 Dec 2013 (actual)
First posted: 10 Aug 2009 (estimated)
Results: Posted 25 Mar 2021

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(3µg) + QS21	Experimental	Biological: ACC-001(3µg) + QS21ACC-001(3µg) + QS21
ACC-001(10µg) + QS21	Experimental	Biological: ACC-001(10µg) + QS21ACC-001(10µg) + QS21
ACC-001(30µg) + QS21	Experimental	Biological: ACC-001(30µg) + QS21ACC-001(30µg) + QS21

Who may qualify

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

Key inclusion criteria (2 listed)

Subjects randomized under previous 3134K1-200 study (NCT00479557) 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 ≥10

Key exclusion criteria (3 listed)

Significant Neurological Disease other than Alzheimer's disease
Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200 study (NCT00479557)
Clinically significant systemic illness

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(3µg) + QS21Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18	Biological	ACC-001(3µg) + QS21
ACC-001(10µg) + QS21Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18	Biological	ACC-001(10µg) + QS21
ACC-001(30µg) + QS21Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18	Biological	ACC-001(30µg) + QS21

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 25 Mar 2021, 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	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 25 Mar 2021.
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.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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

17 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ACC-001(3µg) + QS21, ACC-001(10µg) + QS21 and ACC-001(30µg) + QS21 in people with Alzheimer Disease, run by Pfizer at 17 sites in 3 countries.

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 2 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 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France, Germany, Spain. 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 25 Mar 2021). 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 NCT00955409.

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 Mar 2021.