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ADMET

CompletedPhase 2Results posted

Apathy in Dementia Methylphenidate Trial (ADMET)

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Asset

Methylphenidate

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26

Primary endpoints

•Apathy Evaluation Scale (AES)•Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

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

NCT IDNCT01117181

Org study IDR01AG033032-01https://reporter.nih.gov/quickSearch/R01AG033032-01

NihR01AG033032-01

Timeline

Milestones

Study first posted2010-05-05estimated

Study start2010-06 (month precision)

Primary completion2012-08actual (month precision)

Study completion2012-08actual (month precision)

Results first posted2013-05-10estimated

Last update posted2018-06-12actual

Assets

Drug assets

Methylphenidate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria), with Mini-Mental State Exam (MMSE) score of 10-26 inclusive; MMSE scores above 26 in those who nevertheless meet criteria for AD may be allowed with Steering Committee approval on a case by case basis

•Clinically significant apathy for at least four weeks for which either 1) the frequency of apathy as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or 2) the frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked'

•A medication for apathy is appropriate, in the opinion of the study physician

•Provision of informed consent for participation in the study by patient or surrogate (if the patient is unable to provide informed consent) and caregiver

•Availability of primary caregiver, who spends greater than ten hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study

•Sufficient fluency, of both the patient and caregiver, in written and spoken English to participate in study visits, physical exams, and outcome assessments

•No change to AD medications within the month preceding randomization, including starting, stopping, or dosage modifications

•Treatment with stable doses of selective serotonin reuptake inhibitor antidepressants(SSRIs) is appropriate if stable for 3 months prior to randomization. Other psychotropics(with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis

Exclusion criteria

•Meets criteria for Major Depressive Episode, by Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria

•Clinically significant agitation /aggression for which either 1) the frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'

•Clinically significant delusions for which either 1) the frequency of delusions as assessed by the NPI is 'Very frequently', or 2) the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked'

•Clinically significant hallucinations for which either 1) the frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked'

•Treatment with psychotropic medications in the 2 weeks prior to randomization with the exception of approved treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone (if used as an aid to facilitate sleep and not as an antidepressant); other psychotropics (with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. Note that antipsychotics are expressly prohibited.

•Treatment with methylphenidate is contraindicated in the opinion of the study physician

•Failure of treatment with methylphenidate in the past for apathy after convincing evidence of an adequate trial as judged by study physician

•Treatment with a medication that would prohibit the safe concurrent use of methylphenidate such as monoamine oxidase inhibitors and tricyclic antidepressants

•Need for acute psychiatric hospitalization or is suicidal

•Uncontrolled hypertension (medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS))

•Symptomatic coronary artery disease deemed to be significant by study physician at the time of screening

•Lack of appetite that results in significant unintentional weight loss as determined by the study physician in the last three months

•Significant communicative impairments

•Current participation in a clinical trial or in any study that may add significant burden or affect study outcomes

•Hyperthyroidism, advanced arteriosclerosis, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems

•Glaucoma, pheochromocytoma, or known or suspected hypersensitivity to methylphenidate or its excipients

•Central Nervous System (CNS) abnormalities (e.g., cerebral aneurysm) and/or other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics or a family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or abnormal EEGs

•Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial

Endpoints (16)

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

Behavior / neuropsychiatric

Global cognition

Memory

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Mini-Mental State Exam (MMSE)

Time frame:baseline and 6 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Mini-Mental State Exam (MMSE)

Time frame:baseline and 6 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Methylphenidaten=29 Participants	1.3	0.6
Placebon=31 Participants	-0.3	0.6

Memory

2 endpoints

Secondary/protocol endpoint

Digit Span

Time frame:baseline and 6 weeks

change from baseline, improvement

Secondary/registry result

Digit Span

Time frame:baseline and 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Methylphenidaten=26 Participants	0.46	1.55
Placebon=29 Participants	-0.07	1.25

Behavior / neuropsychiatric

6 endpoints

Primary/protocol endpoint

Apathy Evaluation Scale (AES)

Time frame:baseline to 6 weeks

change from baseline, improvement

Primary/protocol endpoint

Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

Time frame:baseline to 6 weeks

threshold achievement, improvement

Primary/registry result

Apathy Evaluation Scale (AES)

Time frame:baseline to 6 weeks

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Methylphenidaten=29 Participants	-1.9	1.5
Placebon=31 Participants	0.6	1.4

Primary/registry result

Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

Time frame:baseline to 6 weeks

threshold achievement, improvement

Posted result

Group	Value (number), percentage of participants who improve	Reported bounds
Methylphenidaten=29 Participants	21	-
Placebon=31 Participants	3	-

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI): Apathy Subscale

Time frame:baseline to week 6

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Neuropsychiatric Inventory (NPI): Apathy Subscale

Time frame:baseline to week 6

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard error
Methylphenidaten=29 Participants	-4.4	0.6
Placebon=31 Participants	-2.6	0.6

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Electrocardiogram (ECG)

Time frame:6 weeks

descriptive

Secondary/registry result

Electrocardiogram (ECG)

Time frame:6 weeks

descriptive

Posted result

Group	Value (number), participants with abnormal ECG	Reported bounds
Methylphenidaten=29 Participants	20	-
Placebon=31 Participants	15	-

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Vital Status

Time frame:vital status at 6 weeks

categorical status, descriptive

Secondary/registry result

Vital Status

Time frame:vital status at 6 weeks

categorical status, descriptive

Posted result

Group	Value (number), participants who died	Reported bounds
Methylphenidaten=29 Participants	0	-
Placebon=31 Participants	0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Electrolytes

Time frame:6 weeks

descriptive

Secondary/registry result/low confidence

Electrolytes

Time frame:6 weeks

descriptive

Posted result

Group	Value (number), percentage of participants	Reported bounds
MethylphenidateSodiumn=27 Participants	3.70	-
Potassiumn=27 Participants	14.81	-
Chloriden=27 Participants	7.41	-
Bicarbonaten=27 Participants	7.41	-
PlaceboSodiumn=29 Participants	0	-
Potassiumn=29 Participants	10.34	-
Chloriden=29 Participants	10.34	-
Bicarbonaten=29 Participants	10.34	-

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

Rosenberg PB, Lanctot KL, Drye LT, Herrmann N, Scherer RW, Bachman DL, Mintzer JE, ADMET Investigators. Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial. J Clin Psychiatry. 2013 Aug;74(8):810-6. doi: 10.4088/JCP.12m08099.
PMID24021498via DERIVED

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.