Mild Cognitive Impairment
Conditions
Keywords
Memory, Attention, MCI, Ritalin
Brief 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. The investigators 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. The study will be conducted according to a cross-sectional, double-blind, placebo-controlled, 2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI), amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic type, will be recruited from the Orbis Medical Centre. 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.
Interventions
DRUGMethylphenidate
single oral administration of 20 mg tablet
Sponsors
Orbis Medical Centre
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Learning Test Immediate Recall | 140 min after drug intake | — |
| Verbal Learning Test Delayed Recall | 175 min after drug intake | — |
| Verbal Learning Test Recognition | 180 min after drug intake | Accuracy and reaction time |
| Amplitude of the N400 and P600 event-related potential (ERP) components | 140-190 min after drug intake | during encoding and recognition of words of VLT, measured with EEG |
Secondary
| Measure | Time frame |
|---|---|
| Performance on visual and auditory N-back test | 150 minutes after drug intake |
| Amplitude of ERP components during SART | 165 - 170 minutes after drug intake |
| Performance on a sustained attention to response task (SART) | 165 minutes after drug intake |
| Performance on a motor task | 170 minutes after drug intake |
| Amplitude of ERP components during the visual and auditory N-back test | 150-165 minutes after drug intake |
Countries
Netherlands
Contacts
Primary ContactAnke Sambeth, Dr.
Backup ContactWalther Sipers, M.D.
Outcome results
None listed