Can Methylphenidate (Ritalin) improve memory and attention in mild cognitive impairment? An EEG study

Recruiting

Conditions: MCI
geheugenklachten
memory impairment
10009841

Registration Number: NL-OMON41157

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoints are the total number of words recalled at immediate recall<br /><br>in a verbal learning test (VLT); the number of words recalled in VLT at a delay<br /><br>of 30 minutes; accuracy and reaction time of the recognition test of VLT; the<br /><br>amplitude of the N400 and P600 ERP components during encoding and recognition<br /><br>of words of the VLT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are performance on the visual and auditory N-back test, a<br /><br>sustained attention to response tak (SART) and a motor task; amplitude of ERP<br /><br>components during the visual and auditory N-back test, as well as the SART.</p><br>