Alzheimer's DiseaseNCT01082965
Acute Effects Of Donepezil On Brain Perfusion And Memory In Subjects With Cognitive Impairment And Mild Alzheimer's Disease
A study testing Donepezil in people with Alzheimer's Disease, run by Pfizer at 8 sites in United States.
Trial summary
The study hypothesizes that donepezil will have a positive impact on brain blood flow deficits in subjects with memory deficits and/or mild dementia and that improvements in brain blood flow will be accompanied by improvements in memory. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2010to Jul 2012
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects and caregivers must provide written Informed Consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- AD: Diagnostic evidence of probable AD consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria met by the site Physician at the time of the Screening visit. This evidence must be fully documented in the participant's file prior to the Baseline Visit.
- For amnestic Mild Cognitive Impairment (MCI): A Clinical Dementia Rating (CDR) of 0.5 (with memory box score of at least 0.5) and a memory complaint that is objectively verified using a test of episodic memory: Delayed recall from one paragraph of the Wechsler Logical Memory scale (cutoff scores by education - maximum score of 25).
- Less than or equal to 8 for 16 or more years of education; Less than or equal to 4 for 8-15 years of education; Less than or equal to 2 for 0-7 years of education.
- Mini Mental State Exam (MMSE) score of 21-30
- Male and female subjects of non child-bearing potential (or using appropriate birth control measures) who are at least 50 years of age.
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- In generally good health, in the opinion of the Principal Investigator (PI), based on medical history, Body Mass Index (BMI), physical examination, vital signs, 12-lead ECG, and laboratory values, including hematology and chemistry values.
- No known genetic AD causes for early onset memory impairment (e.g., presenilin mutation), participants from a family with known autosomal dominant AD associated with mutations in APP, PS1, or PS2 genes or strongly suspected, but not yet identified mutations in APP, PS1 or PS2 genes or Down's syndrome are not eligible to enroll. Individuals from families with late onset AD with 2 or more affected family members may participate.
- Type II diabetic subjects may be included provided that their disease and serum glucose values are controlled and being actively managed, as assessed by the PI using a fasting blood sugar and/or HgbA1C (per the PI's medical judgment in consultation with the Sponsor).
- Rosen-Modified Hachinski Ischemia Score less than or equal to 4.
Who cannot join
- Diagnosis or history of other possible cause for or significant contributor to dementia, including but not limited to other neurodegenerative disorders (eg, frontotemporal dementia, Lewy body disease, vascular dementia), vitamin B12 deficiency (reflex Methylmalonic Acid (MMA) and folate if B12 is low), untreated thyroid disease, syphilis, alcoholism, severe or recurrent head injury that is clinically relevant to the disease under study, or onset of dementia following heart surgery or cardiac arrest.
- Diagnosis or history of cerebrovascular disease (eg, stroke, transient ischemic attack), severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage, or subdural hematoma that could contribute to the subject's current cognitive or functional status, impair ability to fully participate in the trial or that may impact status during the one week study.
- Specific exclusionary brain MRI findings identified prior to study or at baseline as determined by the investigator that could either contribute to the subject's current cognitive or functional decline impair ability to fully participate in the trial or that may impact status during the trial:
- History of cancer within the last year (except for cutaneous basal cell, squamous cell cancer resolved by excision, colon polyp resolved by excision, or non-progressive prostate cancer per investigator's judgment).
- History of clinically significant cardiovascular or renal events.
- Subjects with uncontrolled hypertension even with therapeutic intervention
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- History of clinically significant (as determined by the PI in consultation with the Sponsor) syncope, seizure, head trauma, or clinically significant unexplained loss of consciousness within the last 5 years.
- A diagnosis of major depressive disorder or other psychiatric illness as the primary diagnosis per the DSM-IV text revision (TR) criteria per the investigator's judgment.
- History of schizophrenia, bipolar disorder, or other severe mental illness.
- Known history of alcohol or drug abuse (as defined by the DSM-IV-TR) within 5 years prior to dosing or a positive result regarding use of illicit drugs on the drug screening test.
- History of clinically significant symptoms of pulmonary disease that requires treatment (eg. asthma, COPD, or other chronic respiratory conditions).
- Known positive Human immunodeficiency virus (HIV) status.
- Unwilling or unable to comply with the Life Style guidelines described in this protocol.
- Exclusions Related to Medications or Procedures
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) of Study Day 1.
- Use of tobacco- or nicotine-containing products within three months of study Day 1.
- Use of medication(s) for cognitive enhancement ≤ 90 days before the first dose of study medication.
- Prescription: including but not limited to donepezil, galantamine, rivastigmine, tacrine, memantine, Axona™;
- Reason for stoppage of donepezil may not be related to tolerability issues or to gain entry in this study.
- Non-prescription treatments for cognitive enhancement.
- Subjects with either non-removable ferromagnetic implants (such as cardiac pacemaker), aneurysm clips or other foreign bodies that would contraindicate a brain MRI scan.
- A clinically significant (as determined by the PI) abnormality in the 12-lead ECG, including complete heart block, bradycardia (heart rate <40 beats/minute), sinus pauses >2 seconds, second or third degree heart block, QTc >450 or other abnormalities judged clinically significant by the PI.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Pfizer Investigational Site
Baltimore, Maryland, 21224
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19446
Pfizer Investigational Site
San Francisco, California, 94122
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
St Louis, Missouri, 63108
Pfizer Investigational Site
St Louis, Missouri, 63110
About this study
Official title: A Methodology Study To Evaluate The Acute Effects Of Donepezil On Regional Cerebral Perfusion And Cognition In Subjects With Amnestic MCI And Mild Alzheimer's Disease
The study hypothesizes that donepezil will have a positive impact on brain blood flow deficits in subjects with memory deficits and/or mild dementia and that improvements in brain blood flow will be accompanied by improvements in memory.
- Conditions
- Alzheimer's Disease
- Being tested
- Donepezil, Placebo
- Keywords
- ASL MRI, perfusion, cognition, donepezil, alzheimer's disease, translational medicine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
5 mg tablets once daily for 7 days and then 10mg on 8th day
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Donepezil |
| 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.
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1
Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
Measured: Baseline, 4 hours post-dose on Day 1
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8
Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
Measured: Baseline, 1 minute post-dose (Hour 0) on Day 8
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8
Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
Measured: Baseline, 4 hours post-dose on Day 8
Secondary outcomes (4)
Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8
Perfusion in anterior cingulate cortex, medial prefrontal cortex, precuneus, inferior parietal cortex and other regions of interest (whole brain gray, superior, medial and inferior temporal cortex; inferior and superior prefrontal cortex; insula, amygdala, thalamus, basal ganglia, hippocampus, Landau) was measured by ASL technique. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for relative perfusion rate. Relative perfusion rate is defined as the absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point.
Measured: Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8
Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8
CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. After 4 pictures were placed correctly, second round started. In second round pictures remain in the same locations, but their order of presentation in the center of the screen was different to that of the first round (randomized). The same process was repeated for round 3 and round 4. The outcome was the number of errors made in correctly placing each of the 4 patterns in their location 4 times.
Measured: Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8
Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8
RAVLT, in immediate recall (IR) list of 15 words (list A) was read aloud to participant 5 times followed by a test of spontaneous retrieval (A1 to A5). After fifth attempt a list of interference, comprising 15 words (list B) was read to participant followed by its retrieval (B1). After attempt B1 examiner asked individual to recall words from list A, without reading it again (A6). Score range: 0-105, higher scores=less impairment. Delayed recall (DR):after a 20-minute interval examiner asked individual to remember words from list A without reading this list; in recognition performance a list comprising 15 words from list A, 15 words from list B, 20 distracting words (similar to words in list A, B) was read to individual. Upon each word read aloud, individual asked to indicate if it belonged to list A, or not. Score range: 0-30, higher scores=less impairment.
Measured: Baseline, 5 hours post-dose on Day 8
Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8
Computerized test battery used to assess detection and identification task. CogState detection task: a measure of simple reaction time, provided valid assessment of psychomotor function. Participants were required to press a "YES" response key as soon as they detected an event (a card turning face up presented in center of the computer screen). The software measured the response time to detect each event. CogState identification task: measure of choice reaction time, provided a valid assessment of visual attention. Participants were required to decide "YES" or "NO" as to whether the event met a predefined and unchanging criterion (is the color of the card red?) while the event (a card turning face up) occurred in the center of the computer screen. The software measured the speed and accuracy of each response.
Measured: Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: The study was terminated because of slow enrollment. The decision to terminate the trial was not based on any safety or efficacy concerns.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 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
- NCT01082965
- Sponsor's protocol ID
- A9001437
- Status last verified
- Jul 2013
- First submitted
- 26 Feb 2010
- Last updated
- 12 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Methodology Study To Evaluate The Acute Effects Of Donepezil On Regional Cerebral Perfusion And Cognition In Subjects With Amnestic MCI And Mild Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01082965
- Acronym / sponsor ID
- A9001437
- Conditions
- Alzheimer's Disease
- Keywords
- ASL MRI, perfusion, cognition, donepezil, alzheimer's disease, translational medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of slow enrollment. The decision to terminate the trial was not based on any safety or efficacy concerns.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Posted 12 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesizes that donepezil will have a positive impact on brain blood flow deficits in subjects with memory deficits and/or mild dementia and that improvements in brain blood flow will be accompanied by improvements in memory.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Donepezil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects and caregivers must provide written Informed Consent and be willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- AD: Diagnostic evidence of probable AD consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria met by the site Physician at the time of the Screening visit. This evidence must be fully documented in the participant's file prior to the Baseline Visit.
- For amnestic Mild Cognitive Impairment (MCI): A Clinical Dementia Rating (CDR) of 0.5 (with memory box score of at least 0.5) and a memory complaint that is objectively verified using a test of episodic memory: Delayed recall from one paragraph of the Wechsler Logical Memory scale (cutoff scores by education - maximum score of 25).
- Less than or equal to 8 for 16 or more years of education; Less than or equal to 4 for 8-15 years of education; Less than or equal to 2 for 0-7 years of education.
- Mini Mental State Exam (MMSE) score of 21-30
Key exclusion criteria (22 listed)
- Diagnosis or history of other possible cause for or significant contributor to dementia, including but not limited to other neurodegenerative disorders (eg, frontotemporal dementia, Lewy body disease, vascular dementia), vitamin B12 deficiency (reflex Methylmalonic Acid (MMA) and folate if B12 is low), untreated thyroid disease, syphilis, alcoholism, severe or recurrent head injury that is clinically relevant to the disease under study, or onset of dementia following heart surgery or cardiac arrest.
- Diagnosis or history of cerebrovascular disease (eg, stroke, transient ischemic attack), severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage, or subdural hematoma that could contribute to the subject's current cognitive or functional status, impair ability to fully participate in the trial or that may impact status during the one week study.
- Specific exclusionary brain MRI findings identified prior to study or at baseline as determined by the investigator that could either contribute to the subject's current cognitive or functional decline impair ability to fully participate in the trial or that may impact status during the trial:
- History of cancer within the last year (except for cutaneous basal cell, squamous cell cancer resolved by excision, colon polyp resolved by excision, or non-progressive prostate cancer per investigator's judgment).
- History of clinically significant cardiovascular or renal events.
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 |
|---|---|---|
| Donepezil5 mg tablets once daily for 7 days and then 10mg on 8th day | Drug | Treatment |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1
Time frame: Baseline, 4 hours post-dose on Day 1
Posterior cingulate cortex perfusion was measured by arterial spin labeling (ASL). ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 0 on Day 8
Time frame: Baseline, 1 minute post-dose (Hour 0) on Day 8
Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 8
Time frame: Baseline, 4 hours post-dose on Day 8
Posterior cingulate cortex perfusion was measured by ASL. ASL is a completely noninvasive magnetic resonance method to measure regional cerebral perfusion. Results are reported for average relative perfusion rate. Average relative perfusion rate is defined as the average absolute perfusion rate divided by the whole brain absolute perfusion rate at the same time point. Average absolute perfusion rate is the average of left absolute perfusion rate and right absolute perfusion rate at the same time point.
4 secondary outcomes
Change From Baseline in Arterial Spin Label (ASL) Perfusion at Hour 4 on Day 1 and at Hour 0, 4 on Day 8
Time frame: Baseline, 4 hours post-dose on Day 1, 1 minute post-dose (Hour 0), 4 hours post-dose on Day 8
Change From Baseline in CogState Continuous Paired Associate Learning (CPAL) at Hour 5 on Day 1 and at Hour 1, 5 on Day 8
Time frame: Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8
Change From Baseline in Rey Auditory Verbal Learning Test (RAVLT): Immediate and Delayed Recall at Hour 5 on Day 8
Time frame: Baseline, 5 hours post-dose on Day 8
Change From Baseline in CogState Test Battery at Hour 5 on Day 1 and at Hour 0, 5 on Day 8
Time frame: Baseline, 5 hours post-dose on Day 1; 1, 5 hours post-dose on Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2013.
- 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.
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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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donepezil in people with Alzheimer's Disease, run by Pfizer at 8 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 10 inclusion and 22 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: stopped early, as of the sponsor's last update on 12 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2013). 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?
Change From Baseline in Posterior Cingulate Cortex Perfusion at Hour 4 on Day 1 (time frame: Baseline, 4 hours post-dose on Day 1). The study lists 3 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 12 Sep 2013.