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Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil | Clinical Trials | Clareo Health

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Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil

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

NCT01712074•Pfizer

View on ClinicalTrials.gov

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. 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.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (60)

ATP Clinical Research, Inc

Costa Mesa, California, United States

Sun Valley Research Center

Imperial, California, United States

Desert Valley Research

Rancho Mirage, California, United States

RAA - Apex Aquisition, LLC

Santa Ana, California, United States

Geriatric and Adult Psychiatry LLC

Hamden, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital, Temple Radiology

New Haven, Connecticut, United States

Yale University School of Medicine, MRI Research Center (MRI)

New Haven, Connecticut, United States

Diagnostic Centers of America

Boynton Beach, Florida, United States

Meridien Research

Brooksville, Florida, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

September 1, 2015

Completion Date

September 1, 2015

Last Updated

March 20, 2017

Enrollment

186

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

PF-05212377 (SAM-760)

DRUG

Placebo

OTHER

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

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