Trial · NCT01117181

Apathy in Dementia Methylphenidate Trial (ADMET)

NCT01117181, Phase 2, Completed, Johns Hopkins Bloomberg School of Public Health; results first posted 2013-05-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Apathy in Dementia Methylphenidate Trial (ADMET). Trials, record NCT01117181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01117181

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Apathy in Dementia Methylphenidate Trial (ADMET)
NCT number: NCT01117181
Status: Completed
Phases: Phase 2
Enrollment: 60 participants, actual
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Conditions: Apathy, Alzheimer's Disease
Interventions: Methylphenidate, placebo, Psychosocial intervention
First posted: 2010-05-05
Last updated: 2018-06-12
Results first posted: 2013-05-10

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Apathy Evaluation Scale (AES)	baseline to 6 weeks	Change in score of Apathy Evaluation Scale from baseline to 6 weeks; the minimum score is 18; the maximum score is 72. Higher scores indicate more severe apathy.
Primary	Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change	baseline to 6 weeks	Proportion of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 weeks; the CGIC is a 7-point Likert scale used to rate each patient with the following scores: "marked worsening"(7), "moderate worsening" (6), "minimal worsening"(5), "no change"(4), "minimal improvement"(3), "moderate improvement"(2), "marked improvement"(1). Ratings were based on an interview with the caregiver and an examination of the patient. The CGIC requires the clinician to consider a number of aspects of apathy, such as level of initiative, level of interest, and emotional engagement.
Secondary	Digit Span	baseline and 6 weeks	Change in Digit Span from baseline to 6 weeks. The Wechsler Adult Intelligence Scale - Revised Digit Span is used to assess auditory attention and working memory. Both forward and backward span is assessed. Both tests consist of six number sequences that the psychometrist reads aloud one at a time. After each sequence is read, the participant must repeat the digits back in the same (forward) or reverse (backward) order. Scores range from 0 to 16, with higher numbers indicate better functioning.
Secondary	Mini-Mental State Exam (MMSE)	baseline and 6 weeks	Change in Mini-Mental State Exam score from baseline to 6 weeks; this cognitive test estimates of dementia severity. Domains included orientation, memory, working memory, naming, following verbal and written commands, spontaneously writing a sentence, and copying two overlapping pentagons. The minimum MMSE score is 0; the maximum MMSE score is 30. Lower MMSE scores indicate more severe cognitive impairment.
Secondary	Neuropsychiatric Inventory (NPI): Apathy Subscale	baseline to week 6	Change from baseline to 6 weeks in neuropsychiatric symptoms in apathy subscore. Frequency (ranges from 1=occasionally, less than once/week to 4 = very frequently, once or more/day or continuously) and severity (1=mild, 2=moderate, 3=severe) scales are scored based on responses from an informed caregiver involved in the patient's life. To obtain the NPI score, the severity score is multiplied by the frequency score. Range is 0 to 12. Larger numbers indicate more severe behavioral disturbance.
Secondary	Vital Status	vital status at 6 weeks	vital status as measured by death
Secondary	Electrolytes	6 weeks	Percent of participants with abnormal electrolyte values at 6 weeks as assessed by local laboratory
Secondary	Electrocardiogram (ECG)	6 weeks	Abnormal electrocardiogram results at 6 weeks

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Apathy Evaluation Scale (AES)	baseline to 6 weeks		units on a scale	MEAN
PRIMARY	Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change	baseline to 6 weeks		percentage of participants who improve	NUMBER
SECONDARY	Digit Span	baseline and 6 weeks		units on a scale	MEAN
SECONDARY	Mini-Mental State Exam (MMSE)	baseline and 6 weeks		units on a scale	MEAN
SECONDARY	Neuropsychiatric Inventory (NPI): Apathy Subscale	baseline to week 6		units on a scale	MEAN
SECONDARY	Vital Status	vital status at 6 weeks		participants who died	NUMBER
SECONDARY	Electrolytes	6 weeks	One patient in the active group completed all visit 6 assessments except for the blood collection for the electrolyte sample. This patient refused this procedure.	percentage of participants	NUMBER
SECONDARY	Electrocardiogram (ECG)	6 weeks		participants with abnormal ECG	NUMBER

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Apathy Evaluation Scale (AES)	Methylphenidate	-1.9	Standard Error 1.5	units on a scale
Apathy Evaluation Scale (AES)	Placebo	0.6	Standard Error 1.4	units on a scale
Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change	Methylphenidate	21		percentage of participants who improve
Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change	Placebo	3		percentage of participants who improve
Digit Span	Methylphenidate	0.46	Standard Deviation 1.55	units on a scale
Digit Span	Placebo	-0.07	Standard Deviation 1.25	units on a scale
Mini-Mental State Exam (MMSE)	Methylphenidate	1.3	Standard Error 0.6	units on a scale
Mini-Mental State Exam (MMSE)	Placebo	-0.3	Standard Error 0.6	units on a scale
Neuropsychiatric Inventory (NPI): Apathy Subscale	Methylphenidate	-4.4	Standard Error 0.6	units on a scale
Neuropsychiatric Inventory (NPI): Apathy Subscale	Placebo	-2.6	Standard Error 0.6	units on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Methylphenidate	29
Overall Study	STARTED	Placebo	31
Overall Study	COMPLETED	Methylphenidate	28
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	Methylphenidate	1
Overall Study	NOT COMPLETED	Placebo	2

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	agitation	Nervous system disorders	Methylphenidate	17	29
other	agitation	Nervous system disorders	Placebo	13	29
other	Anxiety	Nervous system disorders	Methylphenidate	17	29
other	Anxiety	Nervous system disorders	Placebo	10	29
other	weight loss	Metabolism and nutrition disorders	Methylphenidate	10	29
other	weight loss	Metabolism and nutrition disorders	Placebo	4	29
other	abdominal pain	Gastrointestinal disorders	Methylphenidate	6	29
other	abdominal pain	Gastrointestinal disorders	Placebo	4	29
other	Aggressive behavior or hostility	Psychiatric disorders	Methylphenidate	9	29
other	Aggressive behavior or hostility	Psychiatric disorders	Placebo	5	29

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Methylphenidate
Total, all-cause mortality	Placebo
Total, other adverse events	Methylphenidate	29	29
Total, other adverse events	Placebo	29	31
Total, serious adverse events	Methylphenidate	1	29
Total, serious adverse events	Placebo	1	31

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24021498	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AG033032	Apathy in Alzheimer's Disease Methylphenidate Trial	MINTZER, JACOBO; LANCTOT, KRISTA L.; ROSENBERG, PAUL B	MEDICAL UNIVERSITY OF SOUTH CAROLINA	NATIONAL INSTITUTE ON AGING	2009 to 2010

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Methylphenidate vs Placebo: serious adverse events

Source Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Digit Span Test	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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