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Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study
Lead sponsor
Asset
Methylphenidate
Listed sites
1
Recruiting sites
-
Enrollment
60
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•MMSE 18-29•AD symptomatic therapy: stable
Primary endpoint
•Apathy Evaluation Scale Score
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Diagnosis of dementia of the Alzheimer type (DSM-IV Text Revision (TR) criteria)
2. Mini-mental state examination (MMSE) >18, but <29
3. Apathy Evaluation Scale (AES) score of more than 40
4. Ability to provide informed consent by either the patient or caregiver.
5. If subjects are being treated with antidepressants, they should be on a stable dose of antidepressants for at least two months prior to the enrollment into the study.
6. If subjects are being treated with cholinesterase inhibitors and memantine, they should be on stable dose of those medications at least four months prior to the enrollment into the study
Exclusion criteria
1. Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.
2. Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.
3. Uncontrolled hypertension (BP > 140/90) or tachycardia (100) at screening visit
4. Patients with frontotemporal dementia
5. Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)
6. Patients with active psychosis as determined by MINI
7. Patients currently being treated with antipsychotics
8. History of uncontrolled seizure disorder
9. History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.
10. History of Tourette's syndrome or presence of motor tics
11. Patients with glaucoma
12. Patients taking monoamine oxidase inhibitors (MAOIs)
13. Patient taking clonidine
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsMini-mental State Examination (MMSE) at 12 Weeks
Time frame:At 12 weeks
Mini-Mental State Examination (MMSE)
ratio, descriptive
Mini-mental State Examination (MMSE) at 12 Weeks
Time frame:At 12 weeks
Mini-Mental State Examination (MMSE)
ratio, descriptive
Posted result
| Group | Value (mean), units on a scale | Standard deviation |
|---|---|---|
| Methylphenidate Groupn=30 Participants | 25.8 | 2.7 |
| Placebo Groupn=30 Participants | 23.6 | 4 |
Behavior / neuropsychiatric
2 endpointsApathy Evaluation Scale Score at 12 Weeks
Time frame:At 12 weeks
descriptive
Apathy Evaluation Scale Score at 12 Weeks
Time frame:At 12 weeks
descriptive
Posted result
| Group | Value (mean), units on a scale | Standard deviation |
|---|---|---|
| Methylphenidate Groupn=30 Participants | 38.2 | 9.1 |
| Placebo Groupn=30 Participants | 43.6 | 7.5 |
Other clinical outcomes
2 endpointsClinical Global Impression
Time frame:At 12 weeks
change from baseline, improvement
Clinical Global Impression
Time frame:At 12 weeks
change from baseline, improvement
Posted result
| Group | Value (mean), units on a scale | Standard deviation |
|---|---|---|
| Methylphenidate Groupn=30 Participants | 3.9 | 1.1 |
| Placebo Groupn=30 Participants | 4.8 | 0.6 |
Publications (2)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID28945120via DERIVED
- PMID20220576via RESULT
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.