A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
Study Details
Study Description
Brief Summary
Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment (MCI) or mild dementia likely due to Alzheimer's Disease (AD) and related disorders (ADRD).
The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) to treat Attention Deficit/Hyperactivity Disorder (ADHD), 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 mood and cognition.
This study will take place completely virtually (with the option to come in for the first visit to meet the study team). All study visits will occur over a secure videoconferencing platform. All study materials will be shipped directly to the home of each participant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Investigators will give participants a supply of study drug. 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 the next visit.
Weekly Tasks During the study, certain tasks must be done each week.
Every Day:
The following tasks must be done each day throughout the study:
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Wear the Fitbit activity tracker
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Take study medication
Six Days per Week:
The following tasks will be completed six days per week:
- Complete Lumosity cognitive games
o Use Lumosity to rate daily mood and sleep quality
- Synchronize Fitbit to study provided iPad tablet (if requested)
Once every five days:
The following activities must be done approximately every five days throughout the trial:
• Charge Fitbit during a time when the subject is resting but not sleeping
The study coordinator will periodically log into both the Fitbit dashboard and the Lumosity account to check the battery level of the Fitbit, ensure the Fitbit is synching to the Fitbit dashboard, and monitor the completion of Lumosity cognitive exercises.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Methylphenidate During this study, participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. |
Drug: Methylphenidate Extended Release Oral Capsule
Stimulant It can treat ADHD and narcolepsy.
Other Names:
|
| Placebo Comparator: Placebo During this study the participants will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. Placebo is being used in this study to compare to see if any improvements in cognition other areas are due to the study drug or due to other reasons. |
Other: Placebo
Placebo comparator
|
Outcome Measures
Primary Outcome Measures
- Feasibility of a virtual multicrossover randomized control trial design as measured my completion rates and medication compliance. [4 months]
To assess feasibility of this study design, completion rates of all study tasks and medication dosing will be evaluated. Benchmark goals for feasibility measures are set as follows: retain >80% of participants enrolled, observe >80% medication adherence, and >80% outcome assessment completion rates.
- Feasibility of a virtual multicrossover randomized control trial design determined by qualitative participant feedback. [4 months]
Informal qualitative feedback from each participant will be collected throughout the trial and upon study completion to assess their opinions on the tolerability and acceptability of the multicrossover randomized control trial design and of the various study tasks.
Secondary Outcome Measures
- Cognition as measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS) [4 months]
This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease. RBANS scores range from 40 to 160 with higher scores indicating higher cognitive functioning.
- Cognition as measured by daily, home-based brain games (Lumosity, Lumos Labs, Inc.) [4 months]
This study is investigating the effects of methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease using daily Lumosity brain games. The range of possible Lumosity scores varies, but higher scores indicate better game performance.
- Sleep and activity as measured by Fitbit Charge 3 [4 months]
This study is investigating whether treatment with methylphenidate affects sleep and daily activity levels. Methylphenidate may increase daily activity or affect the amount or quality of sleep. Any analyses of activity and sleep will be exploratory.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Study subjects meeting all of the following criteria will be allowed to enroll in the study:
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Aged 55-95 inclusive;
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Diagnosis of MCI or mild-stage dementia presumed due to AD and AD-related disorders;
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Cognitive abilities sufficient to be able to complete all study tasks as determined by the PI or a Co-I;
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Education level, English language skills, and literacy that indicates participant will be able to comprehend all assessments;
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Neuropsychiatric Inventory Agitation/Aggression Question 4 = "No" or "Yes" with a mild severity rating.
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Willing and able to complete all assessments and study procedures;
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Not pregnant, lactating, or of child-bearing potential
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Volunteer has a Study Partner with at least two days per week of contact and willing to complete partner study forms;
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No exclusionary medications or dietary supplements. See Section 6.5.8.1
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If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline.
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Basic video conferencing capabilities and a willingness to participate in a virtual trial (including self-administration of ECG).
Exclusion Criteria:
- Subjects meeting any of the following criteria during the screening evaluation will be excluded:
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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;
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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;
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Major active or chronic psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
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Current suicidal ideation or history of suicide attempt;
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History of alcohol or other substance abuse or dependence with the past two years;
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Clinically significant abnormalities on complete blood count, comprehensive metabolic panel, B12, or TSH screening safety lab results;
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Concomitant use of medications with psychoactive properties that may deleteriously affect cognition (anticholinergics, antihistamines, antipsychotics, sedative hypnotics, anxiolytics);
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Treatment with monoamine oxidase inhibitors, coumadin, phenobarbital, phenytoin, primidone, tricyclic antidepressants or other medicines with potential for clinically significant interaction;
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Hypersensitivity to MPH;
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History of marked anxiety and agitation, ADHD, motor tics, glaucoma, or a history or family history of Tourette's Syndrome;
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Clinically significant cardiac condition for which MPH may be contradicted as determined by study physician, such as MI or ventricular arrhythmia within 6 months of enrollment;
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History of untreated, uncontrolled hypertension or a blood pressure greater than 150/90 during the screening period;
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Use of other small molecule or device- based investigational agents one month prior to entry and for the duration of the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital, Clinical Translational Research Unit | Charlestown | Massachusetts | United States | 02129 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Steven E Arnold, MGH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018P003099