Treatment of Apathy in Alzheimer's Disease With Modafinil

Alzheimer's Disease Clinical Trial

Official title:

Treatment of Apathy in Alzheimer's Disease With Modafinil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01172145
• Other study ID #: 1F32MH075583-01
• Secondary ID: 1F32MH075583-01
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2010
• Last updated: February 9, 2011
• Start date: July 2005
• Est. completion date: September 2007

Study information

• Verified date: September 2010
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 95 Years

Eligibility

Inclusion Criteria:

• diagnosis of mild to moderate stage Probable Alzheimer's disease

• on a stable dose of a cholinesterase inhibitor medication for at least 30 days

• clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

• diagnosis of Major Depression

• focal brain lesion on neuroimaging

• history of significant substance abuse

• history of significant head trauma with loss if consciousness >10 minutes

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Apathy

Intervention

Drug:
• Modafinil
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
• Placebo
100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Brown University	Cephalon, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apathy	The Frontal Systems Behavior Scale. Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.	at baseline	No
Primary	Apathy	The Frontal Systems Behavior Scale.Raw scores are converted to T-Scores using published norms. T-Scores have a mean of 50 and a standard deviation of 10. T-scores less than or equal to 64 are within the average range. T-scores equal to or greater than 65 are indicative of a clinically significant problem. Higher scores indicate greater problem severity.	after 8 weeks of treatment	No
Secondary	Lawton Brody Activities of Daily Living Questionnaire	Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.	at baseline	No
Secondary	The Direct Assessment of Functional Status Scale	A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.	at baseline	No
Secondary	Zarit Burden Inventory	Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.	at baseline	No
Secondary	Lawton Brody Activities of Daily Living Questionnaire	Caregiver reported performance of personal and instrumental activities of daily living (ADLs. There are 6 personal ADLs (i.e. dressing, grooming, eating, etc) and 8 instrumental ADLs (i.e. managing finances, transportation, food preparation) which are assessed. Each item is awarded 2 points for fully independent, 1 point for minimal or moderate support required, and 0 points for full support. Maximum score for independence with all personal and instrumental ADL's is 28.	after 8 weeks of treatment	No
Secondary	The Direct Assessment of Functional Status Scale	A direct, examiner observed assessment of basic and instrumental activities of daily living. Participants are awarded points for correct performance of activities. Raw score is used for statistical comparison.	after 8 weeks of treatment	No
Secondary	Zarit Burden Inventory	Measure of Caregiver Burden. Caregiver rates each item assessing burden on a 0 to 4 point scale with higher numbers reflecting more frequent occurence of the behavior or feeling being assessed.	after 8 weeks of treatment	No