DementiaPhase 4NCT00254033
Apathy Associated With Alzheimer's Disease
A Phase 4 study testing Dextroamphetamine and Methylphenidate in people with Dementia and Alzheimer Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Dextroamphetamine and Methylphenidate
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2003to Oct 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease
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.
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Dextroamphetamine, Methylphenidate
- Keywords
- Alzheimer's Disease, Apathy, Brain Reward System, Dopamine, Dextroamphetamine Challenge, Methylphenidate
- Medical subject headings
- Dementia, Alzheimer Disease, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroamphetamineDrug
MethylphenidateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Research Centre Inventory (ARCI)
Apathy Evaluation Scale-Caregiver (AES-C)
Secondary outcomes (3)
Profile of Mood States (POMS)
Continuous Performance Test (CPT)
Neuropsychiatric Inventory (NPI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startOct 2003
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- American Health Assistance Foundation
- Investigators
- Krista L Lanctot, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254033
- Sponsor's protocol ID
- 065-2003
- Other IDs
- AHAF Grant Number: A2003-236
- Status last verified
- Apr 2017
- First submitted
- 10 Nov 2005
- Last updated
- 28 Apr 2017
- Results posted
- No
Publications
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.
PubMed 18591575
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Dopaminergic Brain Reward System in Apathy Associated With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00254033
- Acronym / sponsor ID
- 065-2003
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- Alzheimer's Disease, Apathy, Brain Reward System, Dopamine, Dextroamphetamine Challenge, Methylphenidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- American Health Assistance Foundation
- Study start
- Oct 2003
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextroamphetamine | Drug | – |
| Methylphenidate | Drug | – |
Primary outcome
Addiction Research Centre Inventory (ARCI)
Apathy Evaluation Scale-Caregiver (AES-C)
3 secondary outcomes
Profile of Mood States (POMS)
Continuous Performance Test (CPT)
Neuropsychiatric Inventory (NPI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Results publication: PubMed 18591575Lanctot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista L Lanctot, PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextroamphetamine and Methylphenidate in people with Dementia and Alzheimer Disease, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Addiction Research Centre Inventory (ARCI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00254033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.