Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495820
Status:
COMPLETED
Last Update Posted:
2015-11-20
First Post:
2007-07-02
Brief Title:
Methylphenidate for Apathy in Alzheimers Dementia A Controlled Study
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Methylphenidate for Apathy in Alzheimers Dementia A Controlled Study
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimers dementia Apathy is one of the earliest and most profound disturbances that occur in Alzheimers dementia AD
Hypotheses 1 Methylphenidate MPH will improve apathy significantly more than placebo in AD
2 Successful treatment of apathy will improve Instrumental Activities of Daily Living IADLs and caregiver burden
Hypotheses 1 Methylphenidate MPH will improve apathy significantly more than placebo in AD
2 Successful treatment of apathy will improve Instrumental Activities of Daily Living IADLs and caregiver burden
Detailed Description:
Objective Apathy is one of the earliest and most profound disturbances that occur in Alzheimers dementia AD Based on promising preliminary data from our open-label pilot study we propose a double blind placebo-controlled randomized clinical trial of methylphenidate for treatment of apathy in AD
Research Design Randomized double blind placebo-controlled study which will evaluate the effect of methylphenidate on apathy and also the impact of improvement of apathy on caregiver burden and functional status
Hypotheses 1 Methylphenidate will improve apathy significantly more than placebo in AD
2 Successful treatment of apathy will improve Instrumental Activities of Daily Living IADLs and caregiver burden
Methodology 60 patients with apathy in the context of AD will be recruited over the next three years In our proposed study patients will be recruited from relevant clinics at the Omaha Veterans Affairs Medical Center VAMC including clinics in Geriatric Psychiatry Neurology Primary Care and Geriatric Medicine 30 patients each with AD and apathy will be randomly assigned to placebo or MPH All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks Patients will be continued in this arm for 12 weeks followed by a 2-week discontinuation phase Patients will be assessed on regular intervals using the Apathy Evaluation Scale Instrumental Activities of Daily Living Zarit Burden Scale and Mini Mental State Examination
Findings None the study is not complete
Clinical Relationships While memory is the key cognitive problem in AD apathy is the key behavioral problem Apathy is characterized by indifference disengagement passivity and lack of enthusiasm interest empathy and interpersonal involvement Apathy is the most common one of the earliest and probably the most persistent of behavioral problems in AD Apathy is the most disturbing behavior to caregivers and has the greatest impact on functional status and caregiver burden
Despite this apathy as a behavioral problem has largely been neglected Most of the research directed towards behavioral problems in dementia is targeted towards more visible behaviors such as agitation and psychosis Remarkably there are no published randomized double blind placebo controlled studies in the treatment of apathy associated with AD
ImpactSignificance Around 14 million veterans suffer from apathy in association with AD Apathy is a strong predictor for functional decline and caregiver burden Treatment of apathy is remarkably understudied and is absolutely critical to allow veterans to maximize their functional status social engagement and quality of life and thus delaying placement in assisted living or nursing home settings
Research Design Randomized double blind placebo-controlled study which will evaluate the effect of methylphenidate on apathy and also the impact of improvement of apathy on caregiver burden and functional status
Hypotheses 1 Methylphenidate will improve apathy significantly more than placebo in AD
2 Successful treatment of apathy will improve Instrumental Activities of Daily Living IADLs and caregiver burden
Methodology 60 patients with apathy in the context of AD will be recruited over the next three years In our proposed study patients will be recruited from relevant clinics at the Omaha Veterans Affairs Medical Center VAMC including clinics in Geriatric Psychiatry Neurology Primary Care and Geriatric Medicine 30 patients each with AD and apathy will be randomly assigned to placebo or MPH All patients in the methylphenidate arm will be started at 5mg twice daily and titrated to 10mg twice daily at two weeks Patients will be continued in this arm for 12 weeks followed by a 2-week discontinuation phase Patients will be assessed on regular intervals using the Apathy Evaluation Scale Instrumental Activities of Daily Living Zarit Burden Scale and Mini Mental State Examination
Findings None the study is not complete
Clinical Relationships While memory is the key cognitive problem in AD apathy is the key behavioral problem Apathy is characterized by indifference disengagement passivity and lack of enthusiasm interest empathy and interpersonal involvement Apathy is the most common one of the earliest and probably the most persistent of behavioral problems in AD Apathy is the most disturbing behavior to caregivers and has the greatest impact on functional status and caregiver burden
Despite this apathy as a behavioral problem has largely been neglected Most of the research directed towards behavioral problems in dementia is targeted towards more visible behaviors such as agitation and psychosis Remarkably there are no published randomized double blind placebo controlled studies in the treatment of apathy associated with AD
ImpactSignificance Around 14 million veterans suffer from apathy in association with AD Apathy is a strong predictor for functional decline and caregiver burden Treatment of apathy is remarkably understudied and is absolutely critical to allow veterans to maximize their functional status social engagement and quality of life and thus delaying placement in assisted living or nursing home settings
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