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Trial record 10 of 439 for:    Methylphenidate

The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02180529
Recruitment Status : Unknown
Verified September 2016 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : July 2, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:

Background: The increase in life expectancy and the rise in the ratio of older to younger people in the population has resulted in an increase in the number of those suffering from a decrease in cognitive ability, such as Mild Cognitive Impairment (MCI). Methylphenidate can improve cognitive ability, mainly in memory and executive function.

Working hypothesis and aims:

This study examines the effect of Ritalin treatment in older people suffering from MCI. Our hypothesis is that treatment with Ritalin will improve cognitive function in those suffering from MCI, especially in the domains of attention and executive function.

Methods A randomized, double-blind, case-control study. 120 patients older than 65 years of age diagnosed as suffering from MCI in the past year in geriatric assessment facilities in Beersheva. Patients will be randomized in equal groups to either the study group (Ritalin treatment) and control group (placebo). Each participant will attend the geriatric unit for four consecutive days: on the day prior to beginning the intervention participants will undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention. Participants in the control group will receive placebo. Two hours after taking the drug or placebo participants in both groups will be assessed cognitively by means of Mindstreams and MoCA (Montreal Cognitive Assessment).

Expected results: Ritalin treatment will improve the cognitive function of the subjects, mainly in the domains of concentration and executive function


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment (MCI) Drug: Methylphenidate Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment: a Randomized, Placebo Controlled, Double-blind Trial.
Study Start Date : November 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention. Two hours after taking the drug participants will be assessed cognitively by means of Mindstreams and MoCA (Montreal Cognitive Assessment).
Drug: Methylphenidate
On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention.
Other Name: Ritalin

Placebo Comparator: Placebo
Participants in the control group will receive placebo. On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of Placebo every day of intervention. Two hours after taking the placebo participants will be assessed cognitively by means of Mindstreams and MoCA (Montreal Cognitive Assessment).
Drug: Placebo



Primary Outcome Measures :
  1. cognitive function [ Time Frame: Twice a day during 3 days ]
    Each participant will attend the geriatric unit for four consecutive days: on the day prior to beginning the intervention participants will undergo cognitive assessment at 9:00 am. On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention. Participants in the control group will receive placebo. Two hours after taking the drug or placebo participants in both groups will be assessed cognitively by means of Mindstreams and MoCA (Montreal Cognitive Assessment).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >65 years old
  • Male and Female
  • Living in the community

Exclusion Criteria:

  • Suffer from unstable conditions, for example, unstable heart disease, severe heart failure, severe renal failure, cirrhosis, blood pressure above 160/100;
  • patient who suffer from glaucoma, hyperthyroididsm, epilepsy, patients after stroke, patient with Parkinson's disease, major depression, schizophrenia or receiving neuroleptic drugs;
  • patient who suffer from dementia
  • patients that recieve treatment in acetylcholinesterase inhibitors or memantine.
  • known sensitivity to methylphenidate.

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): NCT02180529


Locations
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Israel
Clalit Health Service Recruiting
Beer-Sheva, Israel
Contact: Yan Press, M.D    972-8-6477429    yanpr@clalit.org.il   
Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Yan Press, M.D dr.

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02180529     History of Changes
Other Study ID Numbers: MMC0642013
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: September 2016
Keywords provided by Meir Medical Center:
methylphenidate, elderly, mild cognitive impairment
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