A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
Condition: Alzheimer Dementia
MeSH terms: Dementia; Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

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.
    

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.

      For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week
      period (I.e. "A" Blocks 1, 2, 3) and PBO for a two-week period (I.e. "B" Blocks 1, 2, 3) in
      random assignment order for each block. Thus, all volunteers will receive a four-week
      PBO-lead in and acclimatization followed by treatment with MPH or matching PBO for
      eight-weeks each in three randomized sequence crossover blocks for a total of 10 weeks of PBO
      and 6 weeks of MPH.

      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:

        -  Wear the activity tracker

        -  Take study medication

      Six Days per Week:

      The following tasks will be completed six days per week:

        -  Complete online cognitive games

           o Use online brain games to rate daily mood and sleep quality

        -  Synchronize Fitness tracker to study provided tablet (if requested)

      Once every five days:

      The following activities must be done approximately every five days throughout the trial:

      • Charge Fitness tracker during a time when the subject is resting but not sleeping

      The study coordinator will periodically log into both the Fitness tracker dashboard and the
      online brain game account to check the battery level of the Fitness tracker, ensure the
      Fitness tracker is synching to the Fitness tracker dashboard, and monitor the completion of
      cognitive exercises.
    

Intervention name(s): Methylphenidate Extended Release Oral Capsule; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Stimulant It can treat ADHD and narcolepsy.
1 capsule 18mg; Placebo comparator MPH Matched Placebo Tablet
Other intervention name(s): Ritalin
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study uses a double-blinded, multi-crossover, randomized controlled trial design. This type of trial design in AD allow for each subject to serve as their own control as they progress through several randomized blocks of experimental treatment and placebo. Thus, multi-crossover studies carried out with systemically applied outcome measures, pre-specified doses of study drug, and washout periods serve as unbiased estimates of treatment effect for individual subjects. When data from several subjects are analyzed together following such a N-of-1 design, substantial increases in statistical power is afforded with a fraction of the subjects and assessments required for similar levels of power in conventional parallel group trials. There are 6 different block randomization sequences for which subjects were assigned.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care