A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
Condition: Alzheimer Dementia
MeSH terms: Dementia; Alzheimer Disease; Cognitive Dysfunction
Intervention: Methylphenidate Extended Release Oral Capsule; Placebo
Intervention description: Stimulant It can treat ADHD and narcolepsy.
1 capsule 18mg; Placebo comparator MPH Matched Placebo Tablet
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
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)
Enrollment: 11.0
Sex: All
Minimum age: 55 Years
Maximum age: 95 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study subjects meeting all of the following criteria will be allowed to enroll in the
             study:

               1. Aged 55-95 inclusive;

               2. Diagnosis of MCI or mild-stage dementia presumed due to AD and AD-related
                  disorders;

               3. Cognitive abilities sufficient to be able to complete all study tasks as
                  determined by the PI or a Co-I;

               4. Education level, English language skills, and literacy that indicates participant
                  will be able to comprehend all assessments;

               5. Neuropsychiatric Inventory Agitation/Aggression Question 4 = "No" or "Yes" with a
                  mild severity rating.

               6. Willing and able to complete all assessments and study procedures;

               7. Not pregnant, lactating, or of child-bearing potential

               8. Volunteer has a Study Partner with at least two days per week of contact and
                  willing to complete partner study forms;

               9. No exclusionary medications or dietary supplements. See Section 6.5.8.1

              10. If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months
                  prior to baseline.

              11. 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:

               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;

              10. History of marked anxiety and agitation, ADHD, motor tics, glaucoma, or a history
                  or family history of Tourette's Syndrome;

              11. 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;

              12. History of untreated, uncontrolled hypertension or a blood pressure greater than
                  150/90 during the screening period;

              13. Use of other small molecule or device- based investigational agents one month
                  prior to entry and for the duration of the trial.