We aim to examine, in the impaired older population, whether a treatment using methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory.
ID
Source
Brief title
Condition
- Other condition
- Cognitive and attention disorders and disturbances
Synonym
Health condition
geheugenklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are the total number of words recalled at immediate recall
in a verbal learning test (VLT); the number of words recalled in VLT at a delay
of 30 minutes; accuracy and reaction time of the recognition test of VLT; the
amplitude of the N400 and P600 ERP components during encoding and recognition
of words of the VLT.
Secondary outcome
Secondary endpoints are performance on the visual and auditory N-back test, a
sustained attention to response tak (SART) and a motor task; amplitude of ERP
components during the visual and auditory N-back test, as well as the SART.
Background summary
Traditionally, memory impairments in the elderly population are treated using
cholinesterase inhibitors, although impairments remain after treatment.
Dopamine (DA) is also involved in cognition and is especially of interest in
healthy ageing because of the role in processing speed and cognitive control.
To what extent dopamine treatment improves memory and attention in older
impaired individuals is unknown. However, such an effect is conceivable because
of the close relationship between memory and attention in aging and since
improved processing speed and cognitive control may lead to improved memory.
Study objective
We aim to examine, in the impaired older population, whether a treatment using
methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention
and memory.
Study design
The study will be conducted according to a cross-sectional, double-blind,
placebo-controlled, 2-way cross-over design.
Intervention
Participants will be treated once with 20 mg methylphenidate (MPH) and once
with placebo. All medications will be administered orally with a capsule. The
treatment order will be established by counterbalancing.
Study burden and risks
The time investment for the participants will be around 570 min (9.5 hours),
which is comprised of 1) medical screening (60 min), 2) training session of
cognitive tasks (90 min), and 3) two test sessions of around 210 min. The day
before each test day, the participants are not allowed to drink any alcohol.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• The participant has been diagnosed with Mild Cognitive Impairment, either of the amnestic or the non-amnestic type.
• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
• The participant signs and dates a written informed consent form.
• The volunteer is male or female.
• The participant is aged 60 to 80 years, inclusive, at the time of informed consent.
• The participant has a body mass index of 18.5-30, inclusive, at medical screening.
• The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity (corrected or uncorrected) as well as normal hearing (using a whisper test during medical screening).
Exclusion criteria
• The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The subject has uncontrolled hypertension.
• The volunteer has hyperthyroidism.
• The participant has known hypersensitivity to any component of the formulation of MPH or related compounds.
• The participant has glaucoma.
• The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstrain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
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 | EUCTR2014-003117-28-NL |
| CCMO | NL50315.096.14 |