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CompletedPhase 4Results posted

Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

Asset

Methylphenidate

Listed sites

1

Recruiting sites

-

Enrollment

60

actual

Study population

Alzheimer’s disease

Key I/E criteria

Alzheimer's diseaseMMSE 18-29AD 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

Org study IDMHBB-011-06F
NCT IDNCT00495820

Timeline

Milestones

Study first posted2007-07-03estimated
Study start2007-08 (month precision)
Primary completion2010-03actual (month precision)
Study completion2010-06actual (month precision)
Last update posted2015-11-20estimated
Results first posted2015-11-20estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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
Behavior / neuropsychiatric
2
Other clinical outcomes
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Mini-mental State Examination (MMSE) at 12 Weeks

Time frame:At 12 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Secondary/registry result

Mini-mental State Examination (MMSE) at 12 Weeks

Time frame:At 12 weeks

Mini-Mental State Examination (MMSE)

ratio, descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Methylphenidate Groupn=30 Participants25.82.7
Placebo Groupn=30 Participants23.64
p=0.01Mixed Models Analysis

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Apathy Evaluation Scale Score at 12 Weeks

Time frame:At 12 weeks

descriptive

Primary/registry result

Apathy Evaluation Scale Score at 12 Weeks

Time frame:At 12 weeks

descriptive

Posted result

GroupValue (mean), units on a scaleStandard deviation
Methylphenidate Groupn=30 Participants38.29.1
Placebo Groupn=30 Participants43.67.5
p<0.05Mixed Models Analysis

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Clinical Global Impression

Time frame:At 12 weeks

change from baseline, improvement

Secondary/registry result

Clinical Global Impression

Time frame:At 12 weeks

change from baseline, improvement

Posted result

GroupValue (mean), units on a scaleStandard deviation
Methylphenidate Groupn=30 Participants3.91.1
Placebo Groupn=30 Participants4.80.6

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.