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

Primary Purpose

Mild Cognitive Impairment (MCI)

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment (MCI) focused on measuring methylphenidate, elderly, mild cognitive impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clalit Health Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylphenidate

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

cognitive function
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).

Secondary Outcome Measures

Full Information

First Posted
July 1, 2014
Last Updated
February 23, 2021
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02180529
Brief Title
The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment
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 Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
recruiting difficulties
Study Start Date
November 2015 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI)
Keywords
methylphenidate, elderly, mild cognitive impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
cognitive function
Description
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).
Time Frame
Twice a day during 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Press, M.D
Organizational Affiliation
dr.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Service
City
Beer-Sheva
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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