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

This is an interventional supportive care trial for Alzheimer Dementia Read More

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.