The main objective of this project is to study the relationship between dopaminergic mechanisms and apathy in dementia. The related question, both theoretically and of direct relevance for daily practice, is whether patients with dementia are…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in apathy score after the methylphenidate challenge (difference between
before and after the challenge) compared to the change in score after the
placebo condition as measured by the patient version of the Apathy Inventory
(IA)
Secondary outcome
Change in cognitive and other behavioural scores after the methylphenidate
challenge (difference between before and after the challenge) compared to the
change in score after the placebo condition
* on the level of frontal related behaviour, as assessed by specific frontal
related neuropsychological tests like the Verbal Fluency Test, the Stroop
Colour Word Test and five tasks of the CANTAB.
* on the level of novelty seeking behaviour as assessed by a 15 minute
observation of the patient.
Background summary
Apathy is the most frequent neuropsychiatric symptom in dementia. In addition,
it is the most stressful symptom for primary caregivers and has the greatest
negative impact on the quality of the relationship between patient and
caregiver. It is therefore of great importance to gather more knowledge
regarding the pathogenesis of apathy in dementia. Little is known about
neurochemical mechanisms of apathy, but recently, investigators have suggested
that dopaminergic drugs may be useful for reducing apathy in dementia.
Dopaminergic circuits have been related to self-reward and initiating aspects,
and in this respect they are of interest for studies into the pathogenesis of
apathy in dementia. Therefore, it is of importance to study whether
dopaminergic markers are of influence on the development of apathy in dementia.
Study objective
The main objective of this project is to study the relationship between
dopaminergic mechanisms and apathy in dementia. The related question, both
theoretically and of direct relevance for daily practice, is whether patients
with dementia are apathetic primary because problems of initiating or because
of loss of capacities to interact. Is there evidence for deficient functioning
of self-reward and initiation systems, as manipulated by administering a
methylphenidate challenge, in dementia patients and apathy?
Study design
A randomized double-blind placebo-controlled within subjects design.
Intervention
All subjects receive a methylphenidate challenge task or a placebo condition.
All subjects will receive a dose of 10 mg methylphenidate in the challenge
condition.
Study burden and risks
The burden and risks associated with the present study are related to two
visits on two separate days. Each day will start with the administration of a
neuropsychiatric and neuropsychological investigation (2 hour) (clinical
characteristics of the patients will be obtained only on the first day),
observation of spontaneous behaviour (15 minutes), accordingly the
methylphenidate challenge or placebo, and after 1.5 hours the outcome measures
are repeated (around 1.5 hour). Methylphenidate is used in previous studies in
patients with apathy and dementia without reporting of adverse events, so again
burden and risks are expected to be minimal. Because the main objective is to
study the pathogenesis of apathy in dementia, the inclusion of dementia
patients in the present study is necessary.
Dr. Tanslaan 12
6229 ET Maastricht
NL
Dr. Tanslaan 12
6229 ET Maastricht
NL
Listed location countries
Age
Inclusion criteria
-Dementia diagnosed according to the DSM-IV criteria for dementia
-Presence of a reliable informant
-Presence of apathy
-Capable to consent
-Informed consent
Exclusion criteria
-If living in a nursing home at the start of the study
-Patients without a reliable informant
-Concurrent psychiatric disease
-Presence of agitation, irritability, and/or psychotic symptoms
-Use of pharmacological medication
-Use of vasopressors
-Abuse of alcohol and drugs
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-006625-83-NL |
| CCMO | NL16072.068.07 |