Phase 3
N=22
Treatment of Apathy in Alzheimer's Disease With Modafinil
Apathy · Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01172145 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Apathy — 88.91; 95.64 T-score — p=0.181
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Modafinil (Drug); Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apathy |
82.09; 89.09 | — |
| PRIMARY Apathy |
82.09; 89.09 | — |
| SECONDARY Lawton Brody Activities of Daily Living Questionnaire |
19.00; 15.64 | — |
| SECONDARY The Direct Assessment of Functional Status Scale |
88.36; 85.27 | — |
| SECONDARY Zarit Burden Inventory |
30.00; 30.00 | — |
| SECONDARY Lawton Brody Activities of Daily Living Questionnaire |
19.00; 15.64 | — |
| SECONDARY The Direct Assessment of Functional Status Scale |
88.36; 85.27 | — |
| SECONDARY Zarit Burden Inventory |
30.00; 30.00 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01172145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.