Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
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| ClinicalTrials.gov Identifier: NCT01712074 |
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Recruitment Status :
Terminated
(The study was terminated October 23, 2015 as pre-specified, interim analysis futility criteria were met. The termination was not due to safety concerns.)
First Posted : October 23, 2012
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Alzheimer's Disease |
| Interventions |
Drug: PF-05212377 (SAM-760) Other: Placebo |
| Enrollment | 186 |
Participant Flow
| Recruitment Details | Before entering in the 12-week treatment period, participants were required to enter a 4-week placebo run-in period. 195 participants started the placebo run-in period, of which 186 were eligible for the treatment period. Among the 186 enrolled participants, 185 were treated with the double-blind study treatment, 1 was enrolled but not treated. |
| Pre-assignment Details | This study was a multicenter Phase 2a, randomized, placebo controlled, safety and efficacy study of 18 weeks in duration in participants with mild-to-moderate Alzheimer's disease (AD) who were stable on treatment with 5 or 10 mg of donepezil and who had existing neuropsychiatric symptoms. |
| Arm/Group Title | Placebo Run-In | PF-05212377 30 mg: Double Blind Period | Placebo: Double Blind Period |
|---|---|---|---|
 Arm/Group Description |
Participants that received placebo during the 4-week single blind placebo run-in period | All participants that received PF-05212377 30 mg during the 12-week double blind period | All participants that received placebo during the 12-week double blind period |
| Period Title: Placebo Run-in Period | |||
| Started | 195 | 0 | 0 |
| Completed | 185 | 0 | 0 |
| Not Completed | 10 | 0 | 0 |
| Reason Not Completed | |||
| Adverse Event | 2 | 0 | 0 |
| Lost to Follow-up | 1 | 0 | 0 |
| No longer meets eligibility criteria | 5 | 0 | 0 |
| Other | 1 | 0 | 0 |
| No longer willing to participate | 1 | 0 | 0 |
| Period Title: Double Blind Period | |||
| Started | 0 | 91 | 94 |
| Completed | 0 | 77 | 86 |
| Not Completed | 0 | 14 | 8 |
| Reason Not Completed | |||
| Adverse Event | 0 | 2 | 1 |
| No longer willing to participate | 0 | 2 | 4 |
| Death | 0 | 1 | 0 |
| Lost to Follow-up | 0 | 2 | 1 |
| Other | 0 | 4 | 1 |
| Protocol Violation | 0 | 0 | 1 |
| No longer met eligibility criteria | 0 | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | Not Randomized | PF-05212377 30 mg: Double Blind Period | Placebo: Double Blind Period | Total | |
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Arm/Group Description |
Participants who have been discontinued during the Placebo Run-In period | All participants entered the double blind period and received PF-05212377 30 mg | All participants entered the double blind period and received placebo | Total of all reporting groups | |
| Overall Number of Baseline Participants | 9 | 92 | 94 | 195 | |
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Baseline Analysis Population Description |
One (1) of participant randomized but not treated appeared under placebo run-in including his/her discontinued and safety information
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 9 participants | 92 participants | 94 participants | 195 participants | |
| 73.2 (8.8) | 76.0 (8.0) | 75.9 (7.5) | 76 (7.7) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 9 participants | 92 participants | 94 participants | 195 participants | |
| FEMALE |
7 77.8%
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46 50.0%
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55 58.5%
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108 55.4%
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| MALE |
2 22.2%
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46 50.0%
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39 41.5%
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87 44.6%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
| Name/Title: | Pfizer |
| Organization: | Pfizer |
| Phone: | 1-8007181021 |
| EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01712074 |
| Other Study ID Numbers: |
B2081011 2014-000830-42 ( EudraCT Number ) |
| First Submitted: | October 19, 2012 |
| First Posted: | October 23, 2012 |
| Results First Submitted: | August 26, 2016 |
| Results First Posted: | March 20, 2017 |
| Last Update Posted: | March 20, 2017 |