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Apathy Associated With Alzheimer's Disease

Primary Purpose

Dementia, Alzheimer Disease

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Dextroamphetamine
Methylphenidate
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia focused on measuring Alzheimer's Disease, Apathy, Brain Reward System, Dopamine, Dextroamphetamine Challenge, Methylphenidate

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Outcomes

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)

Full Information

First Posted
November 10, 2005
Last Updated
April 26, 2017
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
American Health Assistance Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00254033
Brief Title
Apathy Associated With Alzheimer's Disease
Official Title
The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
American Health Assistance Foundation

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease
Keywords
Alzheimer's Disease, Apathy, Brain Reward System, Dopamine, Dextroamphetamine Challenge, Methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Primary Outcome Measure Information:
Title
Addiction Research Centre Inventory (ARCI)
Title
Apathy Evaluation Scale-Caregiver (AES-C)
Secondary Outcome Measure Information:
Title
Profile of Mood States (POMS)
Title
Continuous Performance Test (CPT)
Title
Neuropsychiatric Inventory (NPI)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krista L Lanctot, PhD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18591575
Citation
Lanctot KL, Herrmann N, Black SE, Ryan M, Rothenburg LS, Liu BA, Busto UE. Apathy associated with Alzheimer disease: use of dextroamphetamine challenge. Am J Geriatr Psychiatry. 2008 Jul;16(7):551-7. doi: 10.1097/JGP.0b013e318170a6d1.
Results Reference
result

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Apathy Associated With Alzheimer's Disease

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