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A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811847
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Steven E Arnold, Massachusetts General Hospital

Brief Summary:

Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment or mild dementia likely due to Alzheimer's Disease.

The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) to treat Attention Deficit/Hyperactivity Disorder, but MPH is not approved by the FDA to treat Mild Cognitive Impairment or mild dementia related to Alzheimer's Disease. However, other studies have been done in which MPH has been given to people with neurodegenerative dementias and results have shown some improvement in these people's mood and cognition. Investigators would like to see if MPH will help your mood and cognition.


Condition or disease Intervention/treatment Phase
Alzheimer Dementia Drug: Methylphenidate Extended Release Oral Capsule Other: Placebo Phase 4

Detailed Description:

Investigators will give participants a supply of study drug to take home with participants. Participants will take the study drug by mouth once a day for 16 weeks. It is important for participants to follow our instructions about how to take the study drug. Participants can take the drug with or without food. Investigators will provide enough study drug for participants to take until your next visit, along with a few extra capsules as back up. Participants will be asked to bring any unused study drug with you to your next study visit.

Your Weekly Tasks During the study, Investigators will ask you to do certain tasks each week.

Every Day:

You will have to do the following tasks each day throughout the study:

  • Wear your Fitbit activity tracker
  • Take your study medication

Six Days per Week:

We will ask you to do the following tasks six days per week:

  • Complete Lumosity cognitive games

    o Use Lumosity to rate your daily mood and sleep quality

  • Synchronize your Fitbit to your study provided iPad tablet

Once every five days:

Investigators will ask you to do the following approximately every five days throughout the trial:

• Charge your Fitbit during a time when you are resting but not sleeping (such as while you are watching TV or reading). Investigators can help remind you to charge your Fitbit if you would like a reminder phone call.

The study coordinator will periodically log into both your Fitbit dashboard and your Lumosity account to check the battery level of your Fitbit, ensure your Fitbit is synching to the Fitbit dashboard, and monitor the completion of Lumosity cognitive exercises.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot, Multiple Crossover, Randomized Block Sequence, Double-Blind, Placebo-Controlled Trial for Use of Methylphenidate for Cognitive and Behavioral Symptoms in Mild Cognitive Impairment and Dementia
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021


Arm Intervention/treatment
Experimental: Methylphenidate
During this study you will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. We will not reveal which you are taking at a given time until the end of the study.
Drug: Methylphenidate Extended Release Oral Capsule
Stimulant It can treat ADHD and narcolepsy.
Other Name: Ritalin

Placebo Comparator: Placebo
During this study you will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. We will not reveal which you are taking at a given time until the end of the study. We are using the placebo in this study to compare if any improvements in your cognition are due to the study drug or due to other reasons.
Other: Placebo
Placebo Comparitive




Primary Outcome Measures :
  1. Cognition as measured by Lumosity Games [ Time Frame: 4 months ]
    We are investigating Methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease. Investigators are asking subjects to play cognitive games on an Ipad Tablet. Investigators expect to see a change in score.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Study subjects meeting all of the following criteria will be allowed to enroll in the study:

    1. Male or female, aged 55-95 inclusive;
    2. Diagnosis of MCI or mild-stage dementia presumed due to AD and AD- related disorders;
    3. Montreal Cognitive Assessment (MoCA) total score 18-28.
    4. Education level, English language skills, and literacy that indicates participant will be able to comprehend all assessments;
    5. Geriatric Depression Scale < 8;
    6. Neuropsychiatric Inventory Agitation/Aggression Question = "No"
    7. Willing and able to complete all assessments and study procedures;
    8. Not pregnant, lactating, or of child-bearing potential
    9. Volunteer has a Study Partner with at least two days per week of contact and willing to complete partner study forms;
    10. No exclusionary medications or dietary supplements. See Section 6.5.8.1
    11. If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline.

Exclusion Criteria:

  • Subjects meeting any of the following criteria during the screening evaluation will be excluded:

    1. Any history of specific CNS disease other than AD or AD-related disorders, such as major clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological or cognitive deficits or complaints;
    2. Clinically significant or unstable medical condition that could affect safety or compliance with the study and would, in the opinion of the investigator, pose a risk to the participant if they were to participate in the study;
    3. Major active or chronic psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
    4. Current suicidal ideation or history of suicide attempt;
    5. History of alcohol or other substance abuse or dependence with the past two years;
    6. Clinically significant abnormalities on complete blood count, comprehensive metabolic panel, B12, or TSH screening safety lab results;
    7. Concomitant use of medications with psychoactive properties that may deleteriously affect cognition (anticholinergics, antihistamines, antipsychotics, sedative hypnotics, anxiolytics);
    8. Treatment with monoamine oxidase inhibitors, coumadin, phenobarbital, phenytoin, primidone, tricyclic antidepressants or other medicines with potential for clinically significant interaction;
    9. Hypersensitivity to MPH;

History of marked anxiety and agitation, ADHD, motor tics, glaucoma, or a history or family history of Tourette's


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): NCT03811847


Contacts
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Contact: Libby Desruisseaux 6176436147 ldesruisseaux@mgh.harvard.edu

Locations
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United States, Massachusetts
Clinical Translational Research Unit Recruiting
Charlestown, Massachusetts, United States, 02124
Contact: Jessica Gerber    617-724-1992    jgerber2@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Steven E Arnold MGH

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Responsible Party: Steven E Arnold, Managing Director Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03811847     History of Changes
Other Study ID Numbers: 2018P003099
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Methylphenidate
Dementia
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cognition 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