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CompletedPhase 4Results posted

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

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 diseaseStudy 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

Org study ID2018P003099
NCT IDNCT03811847

Timeline

Milestones

Study first posted2019-01-22actual
Study start2019-11-01actual
Primary completion2021-08-30actual
Study completion2021-08-30actual
Last update posted2023-06-02actual
Results first posted2023-06-02actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

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.

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

Other (unclassified)
4
Global cognition
2
Behavior / neuropsychiatric
2
Other clinical outcomes
2

Global cognition

2 endpoints
Secondary/protocol endpoint

Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)

Time frame:4 months

categorical status, descriptive

Secondary/registry result

Cognition as Measured by the Repeatable Battery for the Assessment Neuropsychological Status-Update (RBANS)

Time frame:4 months

categorical status, descriptive

Posted result

GroupValue (mean), scores on scaleStandard deviation
Study Participants on MPH Treatmentn=7 Participants68.814.1
Study Participants on PBO Blockn=7 Participants70.713.0

Behavior / neuropsychiatric

2 endpoints
Secondary/protocol endpoint

Sleep as Measured by Fitbit Charge 3

Time frame:4 months

descriptive

Secondary/registry result

Sleep as Measured by Fitbit Charge 3

Time frame:4 months

descriptive

Other clinical outcomes

2 endpoints
Primary/protocol endpoint

Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.

Time frame:4 months

descriptive

Primary/registry result

Feasibility of a Virtual Multicrossover Randomized Control Trial Design as Measured my Completion Rates and Medication Compliance.

Time frame:4 months

descriptive

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
All Study ParticipantsParticipant retentionn=7 Participants7-
Medication Compliancen=7 Participants7-
Assessment completionn=7 Participants7-

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)

Time frame:4 months

descriptive

Secondary/protocol endpoint/low confidence

Activity Level as Measured by Fitbit During MPH/PBO Blocks

Time frame:4 months

descriptive

Secondary/registry result/low confidence

Cognition as Measured by Daily, Home-based Brain Games (Lumosity, Lumos Labs, Inc.)

Time frame:4 months

descriptive

Posted result

GroupValue (mean), scores on a scaleStandard deviation
Study Participants on MPH Blocksn=6 Participants465.8308.4
Study Participants on Placebon=6 Participants451.6291.1
Secondary/registry result/low confidence

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.