Alzheimer's DiseasePhase 2NCT01712074
Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
A Phase 2 study testing PF-05212377 (SAM-760) in people with Alzheimer's Disease, run by Pfizer at 60 sites in 7 countries.
Trial summary
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PF-05212377 (SAM-760)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 60 sitesin 7 countries
- Study dates
- Nov 2012to Sep 2015
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of probable AD with supportive brain imaging documentation
- Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.
Who cannot join
- Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening.
- Have major structural brain disease other than Alzheimer's Disease
- Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
Trial locations and contacts
60 sites in 7 countries.
60 sites in 7 countries
United States40 sites
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Senior Adults Speciality Research Inc.
Austin, Texas, 78757
Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic
Bennington, Vermont, 05201
Diagnostic Centers of America
Boynton Beach, Florida, 33437
Meridien Research
Brooksville, Florida, 34601
Roper Hospital (Imaging Only)
Charleston, South Carolina, 29401
Roper St. Francis Healthcare
Charleston, South Carolina, 29401
Roper St. Francis Pharmacy (IP Shipment/Storage)
Charleston, South Carolina, 29401
Columbus Research & Wellness Institute, Inc.
Columbus, Georgia, 31904
The Ohio State University (administrative offices only)
Columbus, Ohio, 43212
The Ohio State University - 2050
Columbus, Ohio, 43221
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
ATP Clinical Research, Inc
Costa Mesa, California, 92626
Metro Imaging (Imaging only)
Creve Coeur, Missouri, 63141
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
Quantum Laboratories
Deerfield Beach, Florida, 33064
Brain Matters Research Inc
Delray Beach, Florida, 33445
Michigan State University
East Lansing, Michigan, 48824
MD Clinical
Hallandale, Florida, 33009
Geriatric and Adult Psychiatry LLC
Hamden, Connecticut, 06518
Sun Valley Research Center
Imperial, California, 92251
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Compass Research LLC-North Clinic
Leesburg, Florida, 34748
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, 53562
Yale University
New Haven, Connecticut, 06510
Yale-New Haven Hospital, Temple Radiology
New Haven, Connecticut, 06510
Yale University School of Medicine, MRI Research Center (MRI)
New Haven, Connecticut, 06520
Eastside Comprehensive Medical Center, LLC
New York, New York, 10021
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19403
Medical Research Group of Central Florida
Orange City, Florida, 32763
Desert Valley Research
Rancho Mirage, California, 92270
University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center
Rochester, New York, 14620
University of Rochester Medical Center (MRI Imaging Only)
Rochester, New York, 14642
RAA - Apex Aquisition, LLC
Santa Ana, California, 92705
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305
Cary J. Kohlenberg, MD, dba, IPC Research
Waukesha, Wisconsin, 53188
Merrill Hills Manor
Waukesha, Wisconsin, 53226
Premiere Research Institute
West Palm Beach, Florida, 33407
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
Germany5 sites
Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde
Berlin, 10245
Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum
Berlin, 10365
Praxis Dr. sc. med. Alexander Schulze
Berlin, 13156
Arzneimittelforschung Leipzig Gmbh
Leipzig, 04107
Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs
Nuremberg, 90402
United Kingdom5 sites
The Research Institute for the Care of Older People Centre
Bath, BA1 3NG
Fulbourn Hospital
Cambridge, CB21 5EF
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, KT16 0AE
Berrywood Hospital
Northampton, NN5 6UD
Covance Laboratories
Switzerland, 1217
Canada4 sites
Chatham-kent Clinical Trials Research Centre
Chatham, Ontario, N7L 1C1
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, N7M 5L9
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, J8T 8J1
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, B3S 1M7
Chile3 sites
Psicomed Estudios Medicos CIA. LTDA
Antofagasta, Antofagasta, 1270244
Biomedica Research Group
Santiago, Santiago Metropolitan, 7500710
Especialidades Medicas L Y S
Santiago, Santiago Metropolitan, 7560356
Spain2 sites
Hospital General Universitario De Elche
Elche, Alicante, 03203
Hospital de Cantoblanco
Madrid, Madrid, 28049
About this study
Official title: A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-05212377 (SAM-760), Placebo
- Keywords
- Randomized, Double Blind, Safety and Efficacy
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-05212377 (SAM-760)Drug
30 mg QD of PF-05212377 (SAM-760)
PlaceboOther
Placebo QD
| Study group | Role | What they receive |
|---|---|---|
| 30 mg QD of PF-05212377 | Experimental | Not described Receives: Drug: PF-05212377 (SAM-760) |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in ADAS-cog13 Total Score at Week 16
ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
Measured: Baseline and Week 16
Secondary outcomes (1)
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.
Measured: Baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: The study was terminated October 23, 2015 as pre-specified, interim analysis futility criteria were met. The termination was not due to safety concerns.
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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712074
- Sponsor's protocol ID
- B2081011
- Other IDs
- 2014-000830-42, 2014
- Status last verified
- Jan 2017
- First submitted
- 19 Oct 2012
- Last updated
- 20 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9.
PubMed 29622037
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil
- ClinicalTrials.gov ID
- NCT01712074
- Acronym / sponsor ID
- B2081011
- Conditions
- Alzheimer's Disease
- Keywords
- Randomized, Double Blind, Safety and Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated October 23, 2015 as pre-specified, interim analysis futility criteria were met. The termination was not due to safety concerns.
- Enrolment
- 186 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Posted 20 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.
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 |
|---|---|---|
| 30 mg QD of PF-05212377 | Experimental | Drug: PF-05212377 (SAM-760) |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of probable AD with supportive brain imaging documentation
- Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.
Key exclusion criteria (3 listed)
- Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, and/or an inability to complete the ADAS-cog assessment at Screening.
- Have major structural brain disease other than Alzheimer's Disease
- Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
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 |
|---|---|---|
| PF-05212377 (SAM-760)30 mg QD of PF-05212377 (SAM-760) | Drug | 30 mg QD of PF-05212377 |
| PlaceboPlacebo QD | Other | Placebo |
Primary outcome
Change From Baseline in ADAS-cog13 Total Score at Week 16
Time frame: Baseline and Week 16
ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
1 secondary outcome
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
Time frame: Baseline and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29622037Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9.
- 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
60 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-05212377 (SAM-760) in people with Alzheimer's Disease, run by Pfizer at 60 sites in 7 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 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 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Germany, United Kingdom, Canada, Chile and 2 more countries. 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 20 Mar 2017). 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?
Change From Baseline in ADAS-cog13 Total Score at Week 16 (time frame: Baseline and Week 16). 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 NCT01712074, 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 20 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.