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

A Phase 2 study testing ACC-001 and QS-21 in people with Alzheimer's Disease, run by Pfizer at 9 sites in Japan.

Completed

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

Trial summary

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

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Alzheimer's Disease
What is being tested?: ACC-001 and QS-21
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 9 sitesJapan
Study dates: Aug 2009to Jan 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
Mini-Mental State Examination (MMSE) 16-26

Who cannot join

Significant Neurological Disease other than Alzheimer's disease
Major psychiatric disorder
Clinically significant systemic illness

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Japan9 sites

Meitetsu Hospital
Aichi, 451-8511
Ibaraki Prefectural Central Hospital
Ibaraki, 309-1793
Shonan Atsugi Hospital
Kanagawa, 243-8551
Kitasato University East Hospital
Kanagawa, 252-0380
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka, Osaka, 530-8480
The Jikei University School of medicine
Tokyo, 105-8471
Juntendo University Hospital
Tokyo, 113-8431
Juntendo Tokyo Koto Geriatric Medical Center
Tokyo, 136-0075
Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache
Tokyo, 158-8531

Other trials in Japan

About this study

Official title: Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.

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

Conditions: Alzheimer's Disease
Being tested: ACC-001, QS-21
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, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21Other
IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21Other
IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

Study groups in NCT00959192
Study group	Role	What they receive
ACC-001 + QS-21	Experimental	Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 Receives: Biological: ACC-001; Other: QS-21
QS-21	Placebo comparator	Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12 Receives: Other: QS-21

What is being measured

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

Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Number of participants who experienced mild, moderate, or 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 Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Measured: Baseline up to 24 months

Secondary outcomes (2)

Anti-a-beta IgG Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Measured: Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Measured: Baseline up to 24 months

Timeline

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

Aug 2009Jan 2013

First posted14 Aug 2009 (estimated)
Study startAug 2009
Primary completionJan 2013
Study completionJan 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'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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00959192
Sponsor's protocol ID: 3134K1-2206
Other IDs: B2571009
Status last verified: Nov 2015
First submitted: 13 Aug 2009
Last updated: 1 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121.
PubMed 25731629

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's Disease trials

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-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.
ClinicalTrials.gov ID: NCT00959192
Acronym / sponsor ID: 3134K1-2206
Conditions: Alzheimer's Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study start: Aug 2009
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 14 Aug 2009 (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.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ACC-001 + QS-21	Experimental	Biological: ACC-001, Other: QS-21Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21	Placebo comparator	Other: QS-21Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

Who may qualify

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

Key inclusion criteria (2 listed)

Diagnosis of mild to moderate Alzheimer's Disease
Mini-Mental State Examination (MMSE) 16-26

Key exclusion criteria (3 listed)

Significant Neurological Disease other than Alzheimer's disease
Major psychiatric disorder
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-001IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12	Biological	ACC-001 + QS-21
QS-21IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12	Other	ACC-001 + QS-21
QS-21IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12	Other	QS-21

Primary outcome

Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Time frame: Baseline up to 24 months
Number of participants who experienced mild, moderate, or 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 up to 24 months
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.

2 secondary outcomes

Anti-a-beta IgG Titer at Specified Visits
Time frame: Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Time frame: Baseline up to 24 months

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-001 3 Micrograms + QS-21	6	4
ACC-001 10 Micrograms + QS-21	9	8
ACC-001 30 Micrograms + QS-21	9	6
QS-21	8	7

Primary outcome: Incidence of Treatment-emergent Adverse Events (AEs) by Severity

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

Measure	ACC-001 3 Micrograms + QS-21 n = 6	ACC-001 10 Micrograms + QS-21 n = 9	ACC-001 30 Micrograms + QS-21 n = 9	QS-21 n = 8
Mild	4	7	7	5
Moderate	2	1	1	2
Severe	0	0	1	0

Population analysed: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.

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

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

Measure	ACC-001 3 Micrograms + QS-21 n = 6	ACC-001 10 Micrograms + QS-21 n = 9	ACC-001 30 Micrograms + QS-21 n = 9	QS-21 n = 8
Abnormal - inconsistent with AD	1	0	2	0
Abnormal - consistent with AD	6	9	9	8

Population analysed: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.

Primary outcome: Number of Participants With Abnormalities in Neurological Examination

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

Measure	ACC-001 3 Micrograms + QS-21 n = 6	ACC-001 10 Micrograms + QS-21 n = 9
Total	1	1
Mental Status	0	0
Speech	0	0
Cranial Nerves	0	0
Visual Field	0	0
Sensory	1	0
Motor	0	0
Coordination	0	0

Population analysed: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACC-001 3 Micrograms + QS-21	0 of 6 (0%)	6 of 6 (100%)	Not reported
ACC-001 10 Micrograms + QS-21	0 of 9 (0%)	8 of 9 (88.9%)	Not reported
ACC-001 30 Micrograms + QS-21	0 of 9 (0%)	9 of 9 (100%)	Not reported
QS-21	0 of 8 (0%)	7 of 8 (87.5%)	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 25731629Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121.
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

9 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 and QS-21 in people with Alzheimer's Disease, run by Pfizer at 9 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 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 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 9 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. 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 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?

Incidence 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 NCT00959192, 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.