Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712074
First received: October 19, 2012
Last updated: June 4, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: PF-05212377 (SAM-760) Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from Baseline (Week 4) to 12 weeks after the start of double-blind study medication on the ADAS-cog13 total score (Week 16) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline (Week 4) to 12 weeks after the start of double-blind study medication on the NPI total score (Week 16). [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 342 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 30 mg QD of PF-05212377 |
Drug: PF-05212377 (SAM-760)
30 mg QD of PF-05212377 (SAM-760)
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo QD
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712074
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| United States, Arizona | |
| Pfizer Investigational Site | Not yet recruiting |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Costa Mesa, California, United States, 92626 | |
| United States, Connecticut | |
| Pfizer Investigational Site | Recruiting |
| Hamden, Connecticut, United States, 06518 | |
| Pfizer Investigational Site | Not yet recruiting |
| New Haven, Connecticut, United States, 06510 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Brooksville, Florida, United States, 34601 | |
| Pfizer Investigational Site | Recruiting |
| Deerfield Beach, Florida, United States, 33064 | |
| Pfizer Investigational Site | Recruiting |
| Delray Beach, Florida, United States, 33445 | |
| Pfizer Investigational Site | Recruiting |
| Hallandale Beach, Florida, United States, 33009 | |
| Pfizer Investigational Site | Recruiting |
| Tampa, Florida, United States, 33609 | |
| Pfizer Investigational Site | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Pfizer Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30308 | |
| United States, Louisiana | |
| Pfizer Investigational Site | Recruiting |
| Lake Charles, Louisiana, United States, 70629 | |
| United States, Missouri | |
| Pfizer Investigational Site | Not yet recruiting |
| Creve Coeur, Missouri, United States, 63141 | |
| Pfizer Investigational Site | Not yet recruiting |
| St. Louis, Missouri, United States, 63044 | |
| United States, New York | |
| Pfizer Investigational Site | Not yet recruiting |
| Rochester, New York, United States, 14620 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Not yet recruiting |
| Norristown, Pennsylvania, United States, 19403 | |
| United States, Tennessee | |
| Pfizer Investigational Site | Recruiting |
| Cordova, Tennessee, United States, 38018 | |
| United States, Texas | |
| Pfizer Investigational Site | Recruiting |
| Austin, Texas, United States, 78757 | |
| Pfizer Investigational Site | Not yet recruiting |
| Wichita Falls, Texas, United States, 76309 | |
| United States, Vermont | |
| Pfizer Investigational Site | Not yet recruiting |
| Bennington, Vermont, United States, 05201 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | Not yet recruiting |
| Middleton, Wisconsin, United States, 53562 | |
| Pfizer Investigational Site | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Pfizer Investigational Site | Recruiting |
| Waukesha, Wisconsin, United States, 53188 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01712074 History of Changes |
| Other Study ID Numbers: | B2081011 |
| Study First Received: | October 19, 2012 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Randomized Double Blind Safety and Efficacy |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013