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A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
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
Lead sponsor
Asset
Methylphenidate
Listed sites
1
Recruiting sites
-
Enrollment
11
actual
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criteria
•Alzheimer's disease•Study partner/caregiver required
Primary endpoint
•Feasibility of a Virtual Multicrossover Randomized Control Trial Design
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
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
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.
Endpoints (10)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsCognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)
Time frame:4 months
categorical status, descriptive
Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)
Time frame:4 months
categorical status, descriptive
Posted result
| Group | Value (mean), scores on scale | Standard deviation |
|---|---|---|
| Study Participants on MPH Treatmentn=7 Participants | 68.8 | 14.1 |
| Study Participants on PBO Blockn=7 Participants | 70.7 | 13.0 |
Behavior / neuropsychiatric
2 endpointsSleep as Measured by Fitbit Charge 3
Time frame:4 months
descriptive
Sleep as Measured by Fitbit Charge 3
Time frame:4 months
descriptive
Other clinical outcomes
2 endpointsFeasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
Time frame:4 months
descriptive
Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.
Time frame:4 months
descriptive
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| All Study ParticipantsParticipant retentionn=7 Participants | 7 | - |
| Medication Compliancen=7 Participants | 7 | - |
| Assessment completionn=7 Participants | 7 | - |
Other (unclassified)
4 endpointsCognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)
Time frame:4 months
descriptive
Activity Level as Measured by Fitbit During MPH/PBO Blocks
Time frame:4 months
descriptive
Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)
Time frame:4 months
descriptive
Posted result
| Group | Value (mean), scores on a scale | Standard deviation |
|---|---|---|
| Study Participants on MPH Blocksn=6 Participants | 465.8 | 308.4 |
| Study Participants on Placebon=6 Participants | 451.6 | 291.1 |
Activity Level as Measured by Fitbit During MPH/PBO Blocks
Time frame:4 months
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID33308285via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.