Trial · NCT01028911
A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease
NCT01028911, Phase 1, Terminated, Pfizer; results first posted 2014-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease. Trials, record NCT01028911. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01028911
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Tolerability, and Blood Levels of PF-03654746 in Subjects With Mild to Moderate Alzheimer's Disease
- NCT number
- NCT01028911
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Alzheimer's Disease
- Interventions
- PF-03654746, Placebo
- First posted
- 2009-12-09
- Last updated
- 2014-06-04
- Results first posted
- 2014-06-04
- Limitations and caveats
- The study was terminated early due to slow recruitment and the need to use the existing information to determine dosing for another study.
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to 7 to 10 days after last dose | Criteria for potential clinical concern in vital signs: supine and standing systolic blood pressure (SBP) less than (\<) 90 millimeter of mercury (mmHg), supine and standing diastolic BP (DBP) \<50 mmHg, supine pulse rate \<40 beats per minute (bpm) or \>120 bpm, standing pulse rate \<40 bpm or \>140 bpm. Maximum increase or decrease from baseline in supine (Su) and standing (St) SBP \>=30 mmHg and maximum increase or decrease from baseline in supine and standing DBP \>=20 mmHg. |
| Primary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to 7 to 10 days after last dose | Criteria for potential clinical concern in ECG parameters: maximum PR interval of \>=300 milliseconds (msec), maximum QRS interval \>=200 msec, maximum fridericia's corrected QT (QTcF) interval \>=500 msec, PR interval or QRS interval increase from baseline \>=25 percent (%) or 50 percent (%), QTCF interval increase from baseline 30 to 60 msec or \>=60 msec. |
| Primary | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Baseline up to 7 to 10 days after last dose | Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (\< 0.8\*lower limit of normal\[LLN\]); leucocytes (\<0.6/\>1.5\*upper limit of normal \[ULN\]); platelets (\<0.5\*LLN/\>1.75\*ULN); neutrophils, lymphocytes (\<0.8\*LLN/\>1.2\*ULN); eosinophils, basophils, monocytes (\>1.2\*ULN); total bilirubin (\>1.5\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (\>3\*ULN), total protein, albumin (\<0.8\*LLN/\>1.2\*ULN); creatinine, urea (\>1.3\*ULN); glucose (\<0.6\*LLN/\>1.5\*ULN); uric acid (\>1.2\*ULN); sodium, potassium, chloride, calcium, bicarbonate (\<0.9\*LLN/\>1.1\*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs), urine epithelial cells (\>=6 high-powered field), urine bacteria \>20 high-powered field; qualitative urine glucose, ketones, protein values \>=1 in urine dipstick test. Total number of participants with any laboratory abnormalities was reported. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Baseline up to 7 to 10 days after last dose | Physical examination included examination of the skin, eyes, ears, throat, neck, and cardiac, respiratory, gastrointestinal and musculoskeletal systems. The examination assessed the participants for any potential changes in physical status, as determined by the investigator. Any untoward findings identified on physical exams conducted after the administration of the first dose of study medication was captured as an adverse event. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline | Baseline | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5 | Day 5 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10 | Day 10 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15 | Day 15 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20 | Day 20 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
| Primary | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25 | Day 25 | Participant-rated 12-item questionnaire to assess sleep quality and quantity. The items contribute to each scale and are averaged to create the 7 subscale scores: sleep disturbance, snoring, awaken short of breath (ASoB) or with a headache, somnolence, sleep adequacy, sleep quantity (range 0 to 24) and optimal sleep (yes: 1, no: 0), and overall sleep problem index (SPI) I and II. Except for sleep quantity and optimal sleep, scores are transformed (actual raw score minus lowest possible score divided by possible raw score range\* 100); total score range: 0 to 100; higher score = greater intensity of attribute. Except for sleep quantity, sleep adequacy and optimal sleep, higher scores=greater impairment. Scales with at least one item answered was used to generate a scale score. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline up to 7 to 10 days after last dose | Safety population included all participants who took at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities | Baseline up to 7 to 10 days after last dose | Safety population included all participants who took at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Test Abnormalities | Baseline up to 7 to 10 days after last dose | Safety population included all participants who took at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Baseline up to 7 to 10 days after last dose | Safety population included all participants who took at least 1 dose of study drug. | participants | NUMBER |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Baseline | Baseline | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 5 | Day 5 | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 10 | Day 10 | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 15 | Day 15 | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 20 | Day 20 | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
| PRIMARY | Medical Outcomes Study - Sleep Scale (MOS-SS) Score at Day 25 | Day 25 | Safety population included all participants who took at least 1 dose of study drug. | units on a scale | MEAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group241
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinically Significant Vital Sign Abnormalities | PF-03654746 and Donepezil | Supine SBP <90 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Placebo and Donepezil | Supine SBP <90 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | PF-03654746 and Donepezil | Standing SBP <90 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Placebo and Donepezil | Standing SBP <90 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | PF-03654746 and Donepezil | Supine DBP <50 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Placebo and Donepezil | Supine DBP <50 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | PF-03654746 and Donepezil | Standing DBP <50 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Placebo and Donepezil | Standing DBP <50 mmHg | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | PF-03654746 and Donepezil | Supine pulse rate <40 bpm | 0 | participants | |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | Placebo and Donepezil | Supine pulse rate <40 bpm | 0 | participants |
1 to 10 of 241Source ClinicalTrials.gov
See all 241 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03654746 and Donepezil | 7 | |
| Overall Study | STARTED | Placebo and Donepezil | 2 | |
| Overall Study | COMPLETED | PF-03654746 and Donepezil | 7 | |
| Overall Study | COMPLETED | Placebo and Donepezil | 2 | |
| Overall Study | NOT COMPLETED | PF-03654746 and Donepezil | 0 | |
| Overall Study | NOT COMPLETED | Placebo and Donepezil | 0 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | PF-03654746 and Donepezil | 1 | 7 | |
| other | Headache | Nervous system disorders | Placebo and Donepezil | 0 | 2 | |
| other | Abnormal dreams | Psychiatric disorders | PF-03654746 and Donepezil | 1 | 7 | |
| other | Abnormal dreams | Psychiatric disorders | Placebo and Donepezil | 0 | 2 | |
| other | Euphoric mood | Psychiatric disorders | PF-03654746 and Donepezil | 1 | 7 | |
| other | Euphoric mood | Psychiatric disorders | Placebo and Donepezil | 0 | 2 | |
| other | Hypnagogic hallucination | Psychiatric disorders | PF-03654746 and Donepezil | 1 | 7 | |
| other | Hypnagogic hallucination | Psychiatric disorders | Placebo and Donepezil | 0 | 2 | |
| other | Illusion | Psychiatric disorders | PF-03654746 and Donepezil | 1 | 7 | |
| other | Illusion | Psychiatric disorders | Placebo and Donepezil | 0 | 2 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03654746 and Donepezil | ||
| Total, all-cause mortality | Placebo and Donepezil | ||
| Total, other adverse events | PF-03654746 and Donepezil | 5 | 7 |
| Total, other adverse events | Placebo and Donepezil | 0 | 2 |
| Total, serious adverse events | PF-03654746 and Donepezil | 0 | 7 |
| Total, serious adverse events | Placebo and Donepezil | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PF-03654746 and Donepezil vs Placebo and Donepezil: Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Trial comparisons |
| PF-03654746 and Donepezil vs Placebo and Donepezil: Number of Participants With Clinically Significant Laboratory Test Abnormalities | Trial comparisons |
| PF-03654746 and Donepezil vs Placebo and Donepezil: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01028911
GET https://conductscience.org/api/trials/v1/NCT01028911/registered?page=2