Phase 3
Completed N=22
Treatment of Apathy in Alzheimer's Disease With Modafinil
Apathy · Alzheimer's Disease
Source: ClinicalTrials.gov NCT01172145 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Apathy — 88.91; 95.64 T-score — p=0.181
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 | — |
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. Informational only — not medical advice.