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Apathy Associated With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00254033
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : April 28, 2017
American Health Assistance Foundation
Information provided by:
Sunnybrook Health Sciences Centre

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 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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Drug: Dextroamphetamine Drug: Methylphenidate Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease
Study Start Date : October 2003
Actual Study Completion Date : October 2006

Primary Outcome Measures :
  1. Addiction Research Centre Inventory (ARCI)
  2. Apathy Evaluation Scale-Caregiver (AES-C)

Secondary Outcome Measures :
  1. Profile of Mood States (POMS)
  2. Continuous Performance Test (CPT)
  3. Neuropsychiatric Inventory (NPI)

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00254033

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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
American Health Assistance Foundation
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Principal Investigator: Krista L Lanctot, PhD Sunnybrook Health Sciences Centre

Publications of Results:
Layout table for additonal information Identifier: NCT00254033     History of Changes
Other Study ID Numbers: 065-2003
AHAF Grant Number: A2003-236
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Sunnybrook Health Sciences Centre:
Alzheimer's Disease
Brain Reward System
Dextroamphetamine Challenge
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents