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CompletedPhase 4

Apathy Associated With Alzheimer's Disease

The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease

Assets

Dextroamphetamine / Methylphenidate

Listed sites

1

Recruiting sites

-

Enrollment

40

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≥10•AD symptomatic therapy: stable ≥3 months

Primary endpoints

•Addiction Research Centre Inventory (ARCI)•Apathy Evaluation Scale-Caregiver (AES-C)

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 ID065-2003
SecondaryAHAF Grant Number: A2003-236
NCT IDNCT00254033

Timeline

Milestones

Study start2003-10 (month precision)
Study first posted2005-11-15estimated
Study completion2006-10actual (month precision)
Last update posted2017-04-28actual

Assets

Drug assets

DextroamphetamineMethylphenidate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•age > 55 years
•meet DSM-IV criteria for primary degenerative dementia
•meet NINCDS-ARDA criteria for probable Alzheimer's Disease of at least one year's duration
•mild to moderate cognitive impairment (Global Deterioration Scale GDS <6, Mini-Mental State Examination >10
•on a stable dose of a cholinesterase inhibitor for at least 3 months
•apathetic group only: Neuropsychiatric Inventory (NPI) Apathy subscale score >=2

Exclusion criteria

•abnormal biochemical screening: blood cell count, vitamin B12, thyroid function tests, and syphilis screening tests
•significant medical illness or other medical/neurological conditions which diminish cognitive function
•evidence of seizure disorder
•an Hachinski ischemic score >3 indicating vascular dementia
•a brain computed tomographic (CT) scan revealing focal lesions, or inconsistent with AD
•electrocardiographic, laboratory or physical evidence of significant cardiovascular disease
•presence of premorbid or current psychiatric diagnosis including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour (i.e., command hallucinations to harm people or persecutory delusions that provoke violent reactions)
•current or past psychoactive substance abuse or dependence (including alcohol, excluding nicotine)
•contraindications to receiving dextroamphetamine or methylphenidate
•have had administration of a depot neuroleptic injection within one treatment cycle of the first visit

Endpoints (5)

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

Behavior / neuropsychiatric
3
Other (unclassified)
2

Behavior / neuropsychiatric

3 endpoints
Primary/protocol endpoint

Apathy Evaluation Scale-Caregiver (AES-C)

descriptive

Secondary/protocol endpoint

Profile of Mood States (POMS)

descriptive

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Neuropsychiatric Inventory (NPI)

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Addiction Research Centre Inventory (ARCI)

descriptive

Secondary/protocol endpoint/low confidence

Continuous Performance Test (CPT)

descriptive

Publications (1)

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.