Alzheimer's DiseasePhase 1NCT00988598
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
A Phase 1 study testing PF-04447943 in people with Alzheimer's Disease, run by Pfizer at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PF-04447943
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2009to 5 Jul 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects with clinically significant heart disease cannot participate.
- Subjects with a past or current history of seizures cannot participate.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida - Center for Clinical Trials Research
Gainesville, Florida, 32608
Glendale Adventist Medical Center
Glendale, California, 91206
MD Clinical
Hallandale, Florida, 33009
About this study
Official title: A PHASE 1, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR OPEN, RANDOMIZED, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-04447943 IN MILD TO MODERATE ALZHEIMER'S DISEASE SUBJECTS ON STABLE DONEPEZIL THERAPY
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.
- Conditions
- Alzheimer's Disease
- Being tested
- PF-04447943, Placebo
- Keywords
- phase 1 Alzheimer's disease donepezil
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04447943Drug
25 mg of PF-04447943 orally every 12 hours for 7 days
PlaceboDrug
25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| PF-04447943 | Active comparator | Not described Receives: Drug: PF-04447943 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern
Criteria for vital signs abnormalities of potential concern included: supine/standing systolic blood pressure (BP) (less than [<] 90 millimeter of mercury [mmHg], maximum [max] decrease and increase of greater than or equal to [>=] 30 mmHg from baseline); diastolic BP (<50 mmHg, maximum decrease and increase of >=20 mmHg from baseline); supine pulse rate <40 beats per minute [bpm] or greater than [>]120 bpm); standing pulse rate <40 bpm or >140 bpm. Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Measured: Baseline up to Day 10
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern
Criteria for ECG abnormalities of potential clinical concern included: PR interval (>=300 milliseconds [msec], >= 25 percent [%] increase when baseline >200 msec or increase >=50% when baseline less than or equal to [<=] 200 msec); QRS interval (>=200 msec, >= 25% increase when baseline >100 msec or increase >=50% when baseline <=100 msec); QT corrected using Fridericia's formula (QTcF) (>=500 msec, maximum increase between >=30 to <60 msec and >=60 msec). Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Measured: Baseline up to Day 10
Number of Participants With Laboratory Test Abnormalities
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (<0.8*lower limit of normal [LLN]); red blood cell count (<0.8*LLN); platelets (<0.5*LLN or >1.75* upper limit of normal [ULN]); leucocytes (<0.6*LLN or >1.5*ULN); lymphocytes, total neutrophils (<0.8*LLN or >1.2*ULN); basophils, eosinophils, monocytes (>1.2*ULN); total bilirubin (>1.5* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN or >1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN or 1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN or 1.1*ULN); albumin, total protein (<0.8*LLN or 1.2*ULN); urine analysis. Total number of participants with any laboratory abnormalities was reported.
Measured: Baseline up to Day 10
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 after last dose that were absent before treatment or that worsened relative to pretreatment state. Any abnormalities related to physical and neurological findings, laboratory tests, vital signs and ECG were reported as adverse events. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Measured: Baseline up to Day 10
Secondary outcomes (8)
Plasma Concentrations of PF-04447943
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 12 hours.
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Maximum Observed Plasma Concentration (Cmax) of PF-04447943
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Plasma Concentrations of Donepezil
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil
Area under the plasma concentration time-curve from time zero to end of dosing interval (tau), where dosing interval is 24 hours.
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Maximum Observed Plasma Concentration (Cmax) of Donepezil
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil
Measured: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study start26 Oct 2009
- Primary completion5 Jul 2010
- Study completion5 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988598
- Sponsor's protocol ID
- B0401008
- Status last verified
- Oct 2020
- First submitted
- 1 Oct 2009
- Last updated
- 19 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, DOUBLE-BLIND, PLACEBO-CONTROLLED, SPONSOR OPEN, RANDOMIZED, MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF-04447943 IN MILD TO MODERATE ALZHEIMER'S DISEASE SUBJECTS ON STABLE DONEPEZIL THERAPY
- ClinicalTrials.gov ID
- NCT00988598
- Acronym / sponsor ID
- B0401008
- Conditions
- Alzheimer's Disease
- Keywords
- phase 1 Alzheimer's disease donepezil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2009 (actual)
- Primary completion
- 5 Jul 2010 (actual)
- Study completion
- 5 Jul 2010 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Posted 19 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04447943 | Active comparator | Drug: PF-04447943 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects with clinically significant heart disease cannot participate.
- Subjects with a past or current history of seizures cannot participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-0444794325 mg of PF-04447943 orally every 12 hours for 7 days | Drug | PF-04447943 |
| Placebo25 mg matching placebo to PF-04447943 orally every 12 hours for 7 days | Drug | Placebo |
Primary outcome
Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern
Time frame: Baseline up to Day 10
Criteria for vital signs abnormalities of potential concern included: supine/standing systolic blood pressure (BP) (less than [<] 90 millimeter of mercury [mmHg], maximum [max] decrease and increase of greater than or equal to [>=] 30 mmHg from baseline); diastolic BP (<50 mmHg, maximum decrease and increase of >=20 mmHg from baseline); supine pulse rate <40 beats per minute [bpm] or greater than [>]120 bpm); standing pulse rate <40 bpm or >140 bpm. Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Number of Participants With Electrocardiogram (ECG) Abnormalities of Potential Clinical Concern
Time frame: Baseline up to Day 10
Criteria for ECG abnormalities of potential clinical concern included: PR interval (>=300 milliseconds [msec], >= 25 percent [%] increase when baseline >200 msec or increase >=50% when baseline less than or equal to [<=] 200 msec); QRS interval (>=200 msec, >= 25% increase when baseline >100 msec or increase >=50% when baseline <=100 msec); QT corrected using Fridericia's formula (QTcF) (>=500 msec, maximum increase between >=30 to <60 msec and >=60 msec). Baseline is defined as the last pre-dose (PF-04447943) recording at Day 0.
Number of Participants With Laboratory Test Abnormalities
Time frame: Baseline up to Day 10
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit (<0.8*lower limit of normal [LLN]); red blood cell count (<0.8*LLN); platelets (<0.5*LLN or >1.75* upper limit of normal [ULN]); leucocytes (<0.6*LLN or >1.5*ULN); lymphocytes, total neutrophils (<0.8*LLN or >1.2*ULN); basophils, eosinophils, monocytes (>1.2*ULN); total bilirubin (>1.5* ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN or >1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN or 1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN or 1.1*ULN); albumin, total protein (<0.8*LLN or 1.2*ULN); urine analysis. Total number of participants with any laboratory abnormalities was reported.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 10
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 after last dose that were absent before treatment or that worsened relative to pretreatment state. Any abnormalities related to physical and neurological findings, laboratory tests, vital signs and ECG were reported as adverse events. AEs included SAEs as well as non-serious AEs which occurred during the trial.
8 secondary outcomes
Plasma Concentrations of PF-04447943
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04447943
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Maximum Observed Plasma Concentration (Cmax) of PF-04447943
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04447943
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours after morning dose of PF-04447943 on Day 1, Day 7
Plasma Concentrations of Donepezil
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Donepezil
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Maximum Observed Plasma Concentration (Cmax) of Donepezil
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Donepezil
Time frame: 0 hours (pre-dose), 0.5, 1, 3, 8, 12 hours post donepezil administration on Day 0(Baseline), Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04447943 in people with Alzheimer's Disease, run by Pfizer at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Vital Signs Abnormalities of Potential Clinical Concern (time frame: Baseline up to Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.