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Apathy Associated With Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
American Health Assistance Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00254033
First received: November 10, 2005
Last updated: May 21, 2008
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Dementia
Alzheimer Disease
 Drug: Dextroamphetamine
Drug: Methylphenidate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

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

Secondary Outcome Measures:
  • Profile of Mood States (POMS)
  • Continuous Performance Test (CPT)
  • Neuropsychiatric Inventory (NPI)

Estimated Enrollment: 40
Study Start Date: October 2003
Study Completion Date: October 2006
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254033

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

No publications provided

ClinicalTrials.gov Identifier: NCT00254033     History of Changes
Other Study ID Numbers: 065-2003, AHAF Grant Number: A2003-236
Study First Received: November 10, 2005
Last Updated: May 21, 2008
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Alzheimer's Disease
Apathy
Brain Reward System
 Dopamine
Dextroamphetamine Challenge
Methylphenidate

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dextroamphetamine
Methylphenidate
 Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013