Can Ritalin improve memory and attention in participants with memory impairment?
- Conditions
- memory impairment in patients with Mild Cognitive ImpairmentMedDRA version: 17.0Level: LLTClassification code 10027174Term: Memory impairedSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 17.0Level: PTClassification code 10027175Term: Memory impairmentSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003117-28-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• 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
• 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method