Clinical trial NCT02326038: Ritalin, Memory and Attention in MCI: a Behaviour-EEG Study
Official title: Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Keywords: Memory
Attention
MCI
Ritalin
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Orbis Medical Centre
First posted: 2014-12-25
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Verbal Learning Test Immediate Recall
timeFrame: 140 min after drug intake
measure: Verbal Learning Test Delayed Recall
timeFrame: 175 min after drug intake
measure: Verbal Learning Test Recognition
timeFrame: 180 min after drug intake
measure: Amplitude of the N400 and P600 event-related potential (ERP) components
timeFrame: 140-190 min after drug intake
Secondary outcomes:
measure: Performance on visual and auditory N-back test
timeFrame: 150 minutes after drug intake
measure: Performance on a sustained attention to response task (SART)
timeFrame: 165 minutes after drug intake
measure: Performance on a motor task
timeFrame: 170 minutes after drug intake
measure: Amplitude of ERP components during the visual and auditory N-back test
timeFrame: 150-165 minutes after drug intake
measure: Amplitude of ERP components during SART
timeFrame: 165 - 170 minutes after drug intake
Other outcomes:
Locations:
city: Sittard-Geleen
country: Netherlands
facility: Orbis Medical Centre
state: Limburg
Study officials:
affiliation: Maastricht University
name: Anke Sambeth, Dr.
role: PRINCIPAL_INVESTIGATOR
References: