- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02180529
The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment
The Effects of Methylphenidate on the Cognitive Function of Older People With Mild Cognitive Impairment: a Randomized, Placebo Controlled, Double-blind Trial.
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beer-Sheva, Israel
- Clalit Health Service
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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).
|
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 Names:
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Twice a day during 3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yan Press, M.D, Dr.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Cognitive Dysfunction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- MMC0642013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mild Cognitive Impairment (MCI)
-
Charite University, Berlin, GermanyCompletedMild Cognitive Impairment (MCI)Germany
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
-
Immunotec Inc.RecruitingMild Cognitive Impairment (MCI)Canada
-
Mackay Memorial HospitalBened Biomedical Co., Ltd.RecruitingMild Cognitive Impairment (MCI)Taiwan
-
Thomas Jefferson UniversityJohns Hopkins University; University of Pennsylvania; National Institute on Aging... and other collaboratorsCompletedMild Cognitive Impairment (MCI)United States
-
Assaf-Harofeh Medical CenterNeurim Pharmaceuticals Ltd.UnknownMild Cognitive Impairment (MCI)Israel
-
MinYoung Kim, MD, PhDNot yet recruitingPatients With Mild Cognitive Impairment (MCI)
-
Taipei Veterans General Hospital, TaiwanNational Yang Ming Chiao Tung UniversityRecruitingMild Cognitive Impairment (MCI) | Oral Health | Mediterranean DietTaiwan
-
Johns Hopkins UniversityNational Institute on Aging (NIA)CompletedMild Cognitive Impairment (MCI)United States
-
University of California, Los AngelesCompletedMild Cognitive Impairment (MCI) | Age-associated Cognitive ImpairmentUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States