Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030979
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-02-15
Brief Title:
Donepezil to Treat Dementia in Parkinsons Disease
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Donepezil for Dementia in Parkinsons Disease A Randomized Double Blinded Placebo Controlled Crossover Trial
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and effectiveness of donepezil Aricept for treating mild dementia in patients with Parkinsons disease Donepezil is approved for treating patients with Alzheimers disease whose memory and cognition problems are similar to those of patients with Parkinsons 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 Parkinsons 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
Patients 40 years of age and older with Parkinsons 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:
Parkinsons disease PD is the second most common neurodegenerative disorder after Alzheimers 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 Alzheimers 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
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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-N-0115 | None | None | None |