memory impairment in patients with Mild Cognitive Impairment MedDRA version: 17.0 Level: LLT Classification code 10027174 Term: Memory impaired System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10027175 Term: Memory impairment System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Ritalin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We aim to examine, in patients with Mild Cognitive Impairment of the amnestic and those of the non-amnestic type, whether a treatment using methylphenidate, a dopamine re-uptake inhibitor that enhances dopamine, improves memory and attention. This will be assessed using a verbal learning task (VLT), which measures storage, consolidation and retrieval of episodic memory using word lists. The main parameters will be the behavioural scores of the participants as well as the brain responses during this paradigm.;Secondary Objective: In the current study, three different memory/attention paradigms will be used that measure different aspects of memory. In that way, we will obtain a broader view on the effects of methylphenidate on memory. The second test (see the primary objective for the first) is an n-back test (n-back) that assesses most of all attention and partly also updating of working memory. The third task is the Sustained attention to response (SART) test, which examines attention and vigilance. Both behavioural responses during the n-back and SART, as well as the brain responses during these tests, will serve as secondary objective. Finally, a fourth test that specifically examines motor activity (choice reaction time test, CRT) will be used to examine potential beneficial effects on psychomotor activity. ;Primary end point(s): 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 event-related potential (ERP) components during encoding and recognition of words of the VLT, as measured using EEG. ;Timepoint(s) of evaluation of this end point: Immediate recall is assessed 140 minutes after intake of methylphenidate. Delayed recall is assessed 175 minutes after intake of methylphenidate. Delayed recognition is assessed 180 minutes after i | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: The visual and auditory N-back test is performed 150 minutes after methylphenidate intake. The SART is assessed 165 minutes after methylphenidate intake. The motor task is done 170 minutes after intake of methylphenidate. | — |
Countries
Netherlands
Outcome results
None listed