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Trial record 33 of 442 for:    Methylphenidate

Ritalin, Memory and Attention in MCI: a Behaviour-EEG Study

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ClinicalTrials.gov Identifier: NCT02326038
Recruitment Status : Unknown
Verified December 2014 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
Orbis Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center

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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Methylphenidate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Can Methylphenidate (Ritalin) Improve Memory and Attention in Mild Cognitive Impairment? A Combined Behaviour-EEG Study
Study Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Ritalin
Methylphenidate, capsule, 20 mg, single oral administration
Drug: Methylphenidate
single oral administration of 20 mg tablet
Other Name: Ritalin

Placebo Comparator: Placebo
Placebo, capsule, single oral administration



Primary Outcome Measures :
  1. Verbal Learning Test Immediate Recall [ Time Frame: 140 min after drug intake ]
  2. Verbal Learning Test Delayed Recall [ Time Frame: 175 min after drug intake ]
  3. Verbal Learning Test Recognition [ Time Frame: 180 min after drug intake ]
    Accuracy and reaction time

  4. Amplitude of the N400 and P600 event-related potential (ERP) components [ Time Frame: 140-190 min after drug intake ]
    during encoding and recognition of words of VLT, measured with EEG


Secondary Outcome Measures :
  1. Performance on visual and auditory N-back test [ Time Frame: 150 minutes after drug intake ]
  2. Performance on a sustained attention to response task (SART) [ Time Frame: 165 minutes after drug intake ]
  3. Performance on a motor task [ Time Frame: 170 minutes after drug intake ]
  4. Amplitude of ERP components during the visual and auditory N-back test [ Time Frame: 150-165 minutes after drug intake ]
  5. Amplitude of ERP components during SART [ Time Frame: 165 - 170 minutes after drug intake ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326038


Contacts
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Contact: Anke Sambeth, Dr. 0031 43 3881757 anke.sambeth@maastrichtuniversity.nl
Contact: Walther Sipers, M.D. 0031 88 4597783 w.sipers@orbisconcern.nl

Locations
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Netherlands
Orbis Medical Centre Recruiting
Sittard-Geleen, Limburg, Netherlands, 6162BG
Contact: Walther Sipers, M.D.    0031 884597783    w.sipers@orbisconcern.nl   
Sponsors and Collaborators
Maastricht University Medical Center
Orbis Medical Centre
Investigators
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Principal Investigator: Anke Sambeth, Dr. Maastricht University

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02326038     History of Changes
Other Study ID Numbers: 14T111
2014-003117-28 ( EudraCT Number )
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Maastricht University Medical Center:
Memory
Attention
MCI
Ritalin
Additional relevant MeSH terms:
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Methylphenidate
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents