Trial · NCT02346201
Apathy in Dementia Methylphenidate Trial 2
NCT02346201, Phase 3, Completed, Johns Hopkins Bloomberg School of Public Health; results first posted 2023-06-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Apathy in Dementia Methylphenidate Trial 2. Trials, record NCT02346201. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02346201
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Apathy in Dementia Methylphenidate Trial 2
- NCT number
- NCT02346201
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 200 participants, actual
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Conditions
- Apathy, Alzheimer's Disease
- Interventions
- Methylphenidate, Placebo
- First posted
- 2015-01-26
- Last updated
- 2023-06-13
- Results first posted
- 2023-06-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neuropsychiatric Inventory (NPI) | baseline to 6 months | Mean difference in change from baseline to 6 months in the NPI apathy subscale scores as administered by certified personnel to the study caregiver. SEVERITY is graded 1 to 3 and FREQUENCY is graded 1 to 4. The overall score for the domain is the product of the severity and frequency which ranges from 1 to 12 with higher scores indicating more apathy. |
| Primary | Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) | Baseline to month 6 | Percentage of individuals improving on Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) from baseline to 6 months; 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. Reported data is the percentage of participants with minimal/moderate/marked improvement. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Neuropsychiatric Inventory (NPI) | baseline to 6 months | The number of participants with data at 6 months | score on a scale | MEAN |
| PRIMARY | Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) | Baseline to month 6 | The number of participants with data at 6 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neuropsychiatric Inventory (NPI) | Methylphenidate | -4.5 | Standard Deviation 4.1 | score on a scale | |
| Neuropsychiatric Inventory (NPI) | Placebo | -3.1 | Standard Deviation 3.6 | score on a scale | |
| Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) | Methylphenidate | 39 | percentage of participants | ||
| Percentage of Participants With Change in Modified Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change (CGIC) | Placebo | 32 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methylphenidate | 99 | |
| Overall Study | STARTED | Placebo | 101 | |
| Overall Study | COMPLETED | Methylphenidate | 89 | |
| Overall Study | COMPLETED | Placebo | 92 | |
| Overall Study | NOT COMPLETED | Methylphenidate | 10 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events120
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 | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Methylphenidate | 17 | 99 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 12 | 101 | |
| other | aggressive behavior or hostility | Psychiatric disorders | Methylphenidate | 26 | 99 | |
| other | aggressive behavior or hostility | Psychiatric disorders | Placebo | 27 | 101 | |
| other | Agitation | Nervous system disorders | Methylphenidate | 45 | 99 | |
| other | Agitation | Nervous system disorders | Placebo | 53 | 101 | |
| other | Anemia | Blood and lymphatic system disorders | Methylphenidate | 7 | 99 | |
| other | Anemia | Blood and lymphatic system disorders | Placebo | 3 | 101 | |
| other | angina | Cardiac disorders | Methylphenidate | 5 | 99 | |
| other | angina | Cardiac disorders | Placebo | 5 | 101 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methylphenidate | 0 | 99 |
| Total, all-cause mortality | Placebo | 0 | 101 |
| Total, other adverse events | Methylphenidate | 97 | 99 |
| Total, other adverse events | Placebo | 99 | 101 |
| Total, serious adverse events | Methylphenidate | 13 | 99 |
| Total, serious adverse events | Placebo | 9 | 101 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R01AG046543 | Apathy in Alzheimer's Disease Methyphenidate Trial II (ADMET II) | MINTZER, JACOBO; HERRMANN, NATHAN; LANCTOT, KRISTA L.; ROSENBERG, PAUL B; SHADE, DAVID M | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE ON AGING | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methylphenidate vs Placebo: deaths from any cause | Trial comparisons |
| Methylphenidate vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02346201
GET https://conductscience.org/api/trials/v1/NCT02346201/events?page=2