Status:
COMPLETED
Apathy Associated With Alzheimer's Disease
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
American Health Assistance Foundation
Conditions:
Dementia
Alzheimer Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief Summary
Apathy, or lack of motivation, affects up to 80% of Alzheimer's disease (AD) patients. These amotivational symptoms increase patient reliance on caregivers, increase caregiver burden and distress, and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00254033
Start Date
October 1 2003
End Date
October 1 2006
Last Update
April 28 2017
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5