Parkinson DiseasePhase 4NCT00030979
Donepezil to Treat Dementia in Parkinson's Disease
A Phase 4 study testing Donepezil in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating mild dementia in patients with Parkinson's disease. Donepezil is approved for treating patients with Alzheimer's disease, whose memory and cognition problems are similar to those of patients with Parkinson's disease who are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Donepezil
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Mar 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than or equal to 40.
- A clinical diagnosis of Idiopathic PD, stages I-IV, using British Brain Bank Research Diagnostic Criteria.
- Mild to moderate dementia with Mini Mental Status Score of 17-26.
Who cannot join
- The presence of an alternative cause of dementia such as AD or stroke, based on clinical evaluation. Subjects will have serologic screening for reversible causes of dementia, including syphilis, thyroid dysfunction and B12 deficiency.
- Presence of uncontrolled hallucinations-hallucinations that are disruptive such that they would interfere with cognitive testing.
- Anticholinergic or cholinergic therapy within 2 weeks prior to inclusion in the study except for Amantadine and Detrol.
- Patients with unstable or clinically significant medical problems such as cardiac arrhythmia or unstable heart disease (e.g. new onset angina) that would, in the judgment of the investigators, interfere with the safe conduct of the study.
- Patients enrolled in other protocols involving investigational drugs or surgery.
- Severe depression: Geriatric Depression Scale score greater than or equal to 13.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial
This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating mild dementia in patients with Parkinson's disease. Donepezil is approved for treating patients with Alzheimer's disease, whose memory and cognition problems are similar to those of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the breakdown of a chemical messenger called acetylcholine, which is involved in memory and other cognitive functions, and may improve cognition in patients.
Patients 40 years of age and older with Parkinson's disease who have mild to moderate dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately 2 hours each, described below. Candidates will be screened for participation during Visit 1.
Read more
- Visit 1 (screening visit): Study candidates will have a medical history, physical and neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will also undergo neuropsychological testing (tests of memory, language, mood and, other brain functions) and fill out a quality of life questionnaire. Those enrolled will be randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested.
- Visit 2 (week 7): Patients will have a neurological examination and neuropsychological testing and will fill out a quality of life questionnaire.
- Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will stop taking the study medication.
- Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will have their study medication switched. That is, patients previously on placebo will be switched to donepezil, and patients who were taking donepezil will be switched to placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested.
- Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit 2.
This study is being conducted at the National Institutes of Health, the University of Pennsylvania, and Northwestern University
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Dementia is a common problem late in the course of the disease and there is no effective therapy. Dementia severely impairs patients'' functional status and limits the treatment of the motor manifestations of PD. No effective therapy for dementia in PD is available. The pathophysiology of dementia in PD is not completely understood, however, as in AD, it is thought to be related to cholinergic dysfunction.
The proposed study will determine whether a therapeutic intervention with donepezil, an acetylcholinesterase inhibitor, shown to be effective in AD, will improve cognitive function in PD. The study is planned as a 26-week, randomized, double-blind, placebo-controlled, cross-over study of the efficacy and safety of donepezil in PD with dementia. The study is being conducted at the University of Pennsylvania, Brown University, Northwestern University and NINDS.
The primary outcome measure in this trial is the change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). The secondary outcome measures will include other scales of cognitive function, activities of daily living, mood, and quality of life. Tolerability of the drug will be assessed based on the side effect profile, specifically, the effect on motor performance.
- Conditions
- Parkinson Disease
- Being tested
- Donepezil
- Keywords
- Mild Dementia, Acetylcholine, Memory, Hallucinations, Washout, Parkinson Disease, Parkinson's Disease, PD, Dementia
- Medical subject headings
- Parkinson Disease, Hallucinations, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonepezilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2002 (estimated)
- Study startFeb 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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 4
- Primary purpose
- Treatment
- Enrolment
- 28 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030979
- Sponsor's protocol ID
- 020115
- Other IDs
- 02-N-0115
- Status last verified
- Mar 2005
- First submitted
- 15 Feb 2002
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kessler II. Epidemiologic studies of Parkinson's disease. 3. A community-based survey. Am J Epidemiol. 1972 Oct;96(4):242-54. doi: 10.1093/oxfordjournals.aje.a121455. No abstract available.
PubMed 5074681Mayeux R, Stern Y, Rosenstein R, Marder K, Hauser A, Cote L, Fahn S. An estimate of the prevalence of dementia in idiopathic Parkinson's disease. Arch Neurol. 1988 Mar;45(3):260-2. doi: 10.1001/archneur.1988.00520270034017.
PubMed 3341950Levin BE, Tomer R, Rey GJ. Cognitive impairments in Parkinson's disease. Neurol Clin. 1992 May;10(2):471-85.
PubMed 1584185
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT00030979
- Acronym / sponsor ID
- 020115
- Conditions
- Parkinson Disease
- Keywords
- Mild Dementia, Acetylcholine, Memory, Hallucinations, Washout, Parkinson Disease, Parkinson's Disease, PD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Feb 2002
- Study completion
- Mar 2005
- First posted
- 18 Feb 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and effectiveness of donepezil (Aricept) for treating mild dementia in patients with Parkinson's disease. Donepezil is approved for treating patients with Alzheimer's disease, whose memory and cognition problems are similar to those of patients with Parkinson's disease who are affected by dementia. Donepezil prevents the breakdown of a chemical messenger called acetylcholine, which is involved in memory and other cognitive functions, and may improve cognition in patients.
Patients 40 years of age and older with Parkinson's disease who have mild to moderate dementia may be eligible for this 6-month study. It involves 6 clinic visits of approximately 2 hours each, described below. Candidates will be screened for participation during Visit 1.
- Visit 1 (screening visit): Study candidates will have a medical history, physical and neurological examinations, electrocardiogram (EKG), and possibly blood tests. They will also undergo neuropsychological testing (tests of memory, language, mood and, other brain functions) and fill out a quality of life questionnaire. Those enrolled will be randomly assigned to receive either donepezil (5 mg per day) or placebo-a look-alike pill with no active ingredients. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested.
- Visit 2 (week 7): Patients will have a neurological examination and neuropsychological testing and will fill out a quality of life questionnaire.
- Visit 3 (week 10): Patients will repeat the evaluations done during visit 2 and will stop taking the study medication.
- Visit 4 (week 16): Patients will repeat the evaluations done during visit 2 and will have their study medication switched. That is, patients previously on placebo will be switched to donepezil, and patients who were taking donepezil will be switched to placebo. After 4 weeks, the dose of donepezil will be increased to 10 mg per day. Patients who do not tolerate the higher dose will have it reduced to 5 mg. Those who do not tolerate the 5-mg dose will be taken off medication but will continue to be followed and tested.
- Visits 5 and 6 (weeks 23 and 26): Patients will repeat the evaluations done during visit 2.
This study is being conducted at the National Institutes of Health, the University of Pennsylvania, and Northwestern University
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease (AD). Dementia is a common problem late in the course of the disease and there is no effective therapy. Dementia severely impairs patients'' functional status and limits the treatment of the motor manifestations of PD. No effective therapy for dementia in PD is available. The pathophysiology of dementia in PD is not completely understood, however, as in AD, it is thought to be related to cholinergic dysfunction.
The proposed study will determine whether a therapeutic intervention with donepezil, an acetylcholinesterase inhibitor, shown to be effective in AD, will improve cognitive function in PD. The study is planned as a 26-week, randomized, double-blind, placebo-controlled, cross-over study of the efficacy and safety of donepezil in PD with dementia. The study is being conducted at the University of Pennsylvania, Brown University, Northwestern University and NINDS.
The primary outcome measure in this trial is the change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). The secondary outcome measures will include other scales of cognitive function, activities of daily living, mood, and quality of life. Tolerability of the drug will be assessed based on the side effect profile, specifically, the effect on motor performance.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 40.
- A clinical diagnosis of Idiopathic PD, stages I-IV, using British Brain Bank Research Diagnostic Criteria.
- Mild to moderate dementia with Mini Mental Status Score of 17-26.
Key exclusion criteria (7 listed)
- The presence of an alternative cause of dementia such as AD or stroke, based on clinical evaluation. Subjects will have serologic screening for reversible causes of dementia, including syphilis, thyroid dysfunction and B12 deficiency.
- Presence of uncontrolled hallucinations-hallucinations that are disruptive such that they would interfere with cognitive testing.
- Anticholinergic or cholinergic therapy within 2 weeks prior to inclusion in the study except for Amantadine and Detrol.
- Patients with unstable or clinically significant medical problems such as cardiac arrhythmia or unstable heart disease (e.g. new onset angina) that would, in the judgment of the investigators, interfere with the safe conduct of the study.
- Patients enrolled in other protocols involving investigational drugs or surgery.
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 |
|---|---|---|
| Donepezil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 5074681Kessler II. Epidemiologic studies of Parkinson's disease. 3. A community-based survey. Am J Epidemiol. 1972 Oct;96(4):242-54. doi: 10.1093/oxfordjournals.aje.a121455. No abstract available.
- Background: PubMed 3341950Mayeux R, Stern Y, Rosenstein R, Marder K, Hauser A, Cote L, Fahn S. An estimate of the prevalence of dementia in idiopathic Parkinson's disease. Arch Neurol. 1988 Mar;45(3):260-2. doi: 10.1001/archneur.1988.00520270034017.
- Background: PubMed 1584185Levin BE, Tomer R, Rey GJ. Cognitive impairments in Parkinson's disease. Neurol Clin. 1992 May;10(2):471-85.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Donepezil in people with Parkinson Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site 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 3 inclusion and 7 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 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00030979, which also lists 3 linked publications.
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 4 Mar 2008.