A Phase 4 interventional study of Dextroamphetamine and Methylphenidate in Dementia and Alzheimer Disease, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2017-04-28.
Sponsored by Sunnybrook Health Sciences Centre · Phase 4, Interventional, and Treatment
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 increase the risk of patient institutionalization. Only 50% of patients with apathy respond to current treatment with cholinesterase inhibitors. The mechanism of apathy in AD is unknown hampering rational treatment. Our proposed pilot study will provide initial data required to develop an amphetamine challenge paradigm to probe the brain reward system. These results will be used to develop a larger study evaluating the role of the brain reward system in apathy in AD and link this information with pharmacologic treatment. AD is a complex neurobiological illness that needs to be understood at several levels to optimize treatment. At a neurochemical level, one has to identify the neurotransmitter abnormalities that accompany the clinical symptoms. The neurochemical level of analysis provides the link between pathology and symptoms and, for now, is the only avenue for biological therapies. Next, one has to translate knowledge of neurochemical abnormalities to practical treatments for the symptoms of AD. This pilot will allow us to develop a study that can address both of these goals. Furthermore, the larger study will further define the emerging concept of apathy as a syndrome and has broader implications for apathy in many other neuropsychiatric diseases.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Addiction Research Centre Inventory (ARCI)
Apathy Evaluation Scale-Caregiver (AES-C)
Profile of Mood States (POMS)
Continuous Performance Test (CPT)
Neuropsychiatric Inventory (NPI)
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre