Phase 1
Completed N=15
A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease
Source: ClinicalTrials.gov NCT00988598 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern — 0; 0; 0; 0 participants
Summary
The purpose of the study is to evaluate the safety of PF-04447943 when given in combination with donepezil in subjects who have Alzheimer's Disease. The study will also evaluate the absorption and distribution of both PF-04447943 and donepezil.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities |
4; 4 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 0; 0; 0 | — |
| SECONDARY Plasma Concentrations of PF-04447943 |
0.01050; 179.6; 296.7; 225.9; 91.76; 51.99 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943 |
1657; 2140 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of PF-04447943 |
303.8; 390.9 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943 |
1.00; 0.767 | — |
| SECONDARY Plasma Concentrations of Donepezil |
29.30; 19.10; 29.93; 23.92; 41.08; 36.18 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil |
426.8; 380.6; 513.4; 565.2 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Donepezil |
47.60; 42.48; 52.88; 59.61 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil |
3.00; 3.00; 3.00; 3.00 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have Alzheimer's dementia with a Mini Mental State Examination score between 18-26, inclusive.
- Subjects must have a reliable caregiver.
- Subjects must be on Aricept
- Memantine is allowed if subjects are on a stable dose
- Subjects must be in reasonably good health, based on medical history, physical examination, vital signs, and ECG, with no serious or unstable disease within the past 3 months.
Exclusion Criteria
- Subjects with clinically significant heart disease cannot participate.
- Subjects with a past or current history of seizures cannot participate.
Data sourced from ClinicalTrials.gov (NCT00988598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.