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

A Phase 2 study testing ACC-001 in people with Alzheimer's Disease, run by Pfizer at 11 sites in Japan.

Terminated

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

Trial summary

The purpose of this long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies. Read more about this study

Who is it for?: Ages 52 to 87 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: ACC-001
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 11 sitesJapan
Study dates: Dec 2010to 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 52 to 87 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
MMSE score 10 and above.

Who cannot join

Significant neurological diseases other than AD.
Brain MRI evidence of vasogenic edema during the preceding studies.
Clinically significant illness.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Japan11 sites

Shonan Atsugi Hospital
Atsugi, Kanagawa, 243-8551
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793
Juntendo Tokyo Koto Geriatric Medical Center
Koto-ku, Tokyo, 136-0075
The Tokyo Jikei University School of Medicine
Minato-ku, Tokyo, 105-8471
Meitetsu Hospital
Nagoya, Aichi-ken, 451-8511
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, 530-8480
Kitasato University East Hospital
Sagamihara-shi, Kanagawa, 252-0380
Kanto Central Hospital of the Mutual Aid Association of Public School Teachers
Setagaya-ku, Tokyo, 158-8531
Suwa Red Cross Hospital
Suwa, Nagano, 392-8510
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686

Other trials in Japan

About this study

Official title: A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease

Conditions: Alzheimer's Disease
Being tested: 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-001Biological
IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
ACC-001Biological
IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
ACC-001Biological
IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18

Study groups in NCT01238991
Study group	Role	What they receive
ACC-001 (3 micrograms) + QS-21	Experimental	Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 Receives: Biological: ACC-001
ACC-001 (10 micrograms) + QS-21	Experimental	Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 Receives: Biological: ACC-001
ACC-001 (30 micrograms) + QS-21	Experimental	Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 Receives: Biological: ACC-001

What is being measured

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

Number of Treatment Emergent Adverse Events (AEs) by Severity
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Measured: Baseline up to 24 months
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Measured: Baseline up to 24 months
Number of Participants With Abnormalities in Neurological Examination
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.
Measured: Baseline of the preceding studies through 24 months of this study

Timeline

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

Dec 2010Dec 2013

First posted11 Nov 2010 (estimated)
Study startDec 2010
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'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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01238991
Sponsor's protocol ID: B2571001
Other IDs: 3134K1-2207
Status last verified: Dec 2014
First submitted: 21 Oct 2010
Last updated: 22 Dec 2014
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

RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease

All Alzheimer's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT01238991
Acronym / sponsor ID: B2571001
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 53 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Dec 2010
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 11 Nov 2010 (estimated)
Results: Posted 22 Dec 2014

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
ACC-001 (3 micrograms) + QS-21	Experimental	Biological: ACC-001Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (10 micrograms) + QS-21	Experimental	Biological: ACC-001Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18
ACC-001 (30 micrograms) + QS-21	Experimental	Biological: ACC-001Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18

Who may qualify

Ages: 52 to 87 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria.
Screening brain MRI scan is consistent with the diagnosis of AD.
MMSE score 10 and above.

Key exclusion criteria (3 listed)

Significant neurological diseases other than AD.
Brain MRI evidence of vasogenic edema during the preceding studies.
Clinically significant 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-001IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18	Biological	ACC-001 (3 micrograms) + QS-21
ACC-001IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18	Biological	ACC-001 (10 micrograms) + QS-21
ACC-001IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18	Biological	ACC-001 (30 micrograms) + QS-21

Primary outcome

Number of Treatment Emergent Adverse Events (AEs) by Severity
Time frame: Baseline up to 24 months
Number of mild, moderate, and severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Time frame: Baseline up to 24 months
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Number of Participants With Abnormalities in Neurological Examination
Time frame: Baseline of the preceding studies through 24 months of this study
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes.

Results and safety

Results posted to the registry on 22 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3 μg ACC-001+QS-21	7	5
QS-21+(3 μg ACC-001+QS-21)	3	3
10 μg ACC-001+QS-21	11	5
10 μg ACC-001+ (10 μg ACC-001+QS-21)	6	4
QS-21+(10 μg ACC-001+QS-21)	5	3
PBS+(10 μg ACC-001+QS-21)	2	2
30 μg ACC-001+QS-21	8	0
30 μg ACC-001+(30 μg ACC-001+QS-21)	5	0
QS-21+(30 μg ACC-001+QS-21)	4	0
PBS+(30 μg ACC-001+QS-21)	2	0

Primary outcome: Number of Treatment Emergent Adverse Events (AEs) by Severity

Time frame: Baseline up to 24 months. Number. Unit: Events

Measure	3 μg ACC-001 Treat n = 7	3 μg Control n = 3	10 μg ACC-001 Treat n = 17	10 μg Control n = 7	30 μg ACC-001 Treat n = 13	30 μg Control n = 6
Mild	14	7	97	38	28	17
Moderate	2	0	14	2	3	4
Severe	0	0	6	0	2	0

Population analysed: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.

Primary outcome: Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data

Time frame: Baseline up to 24 months

Population analysed: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study. Since the study was early terminated and the data could not be obtained as planned, the MRI data were not summarized.

Primary outcome: Number of Participants With Abnormalities in Neurological Examination

Time frame: Baseline of the preceding studies through 24 months of this study. Number. Unit: Participants

Measure	10 μg ACC-001 Treat n = 17	30 μg ACC-001 Treat n = 13	30 μg Control n = 6
Mental Status	2	0	1
Speech	1	0	0
Cranial Nerve Function	0	0	0
Cranial Nerve II	1	0	0
Sensory Function	0	0	1
Motor Function	0	0	0
Coordination	0	0	0
Gait and Station	2	1	0

Population analysed: The population for safety analysis consisted of all enrolled participants who received at least one injection of study medication in this study.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3μg ACC-001 Treat	0 of 7 (0%)	7 of 7 (100%)	Not reported
3μg Control	0 of 3 (0%)	3 of 3 (100%)	Not reported
10ug ACC-001 Treat	7 of 17 (41.2%)	15 of 17 (88.2%)	Not reported
10μg Control	1 of 7 (14.3%)	5 of 7 (71.4%)	Not reported
30μg ACC-001 Treat	2 of 13 (15.4%)	10 of 13 (76.9%)	Not reported
30μg Control	0 of 6 (0%)	6 of 6 (100%)	Not reported
Total	10 of 53 (18.9%)	46 of 53 (86.8%)	Not reported

Limitations and caveats (from the sponsor): Since the study was early terminated and the data could not be obtained as planned, only part of the immunogenicity and safety results were summarized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
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.

Related trials for Alzheimer's Disease

RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingPhase 1
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
Alzheimer s Disease

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

11 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 in people with Alzheimer's Disease, run by Pfizer at 11 sites in Japan.

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: stopped early, as of the sponsor's last update on 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Japan. 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 22 Dec 2014). 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?

Number of Treatment Emergent Adverse Events (AEs) by Severity (time frame: Baseline up to 24 months). The study lists 3 primary outcomes in all. 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 NCT01238991.

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 22 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.