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NCT03811847 · ClinicalTrials.gov registry record · Phase 4
A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03811847: Completed Phase 4 study, sponsored by Massachusetts General Hospital.
NCT03811847 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03811847, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment (MCI) or mild dementia likely due to Alzheimer's Disease (AD) and related disorders (ADRD). The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) to treat Attention Deficit/Hyperactivity Disorder (ADHD), but MPH is not approved by the FDA to treat Mild Cognitive Impairment or mild dementia related to Alzheimer's Disease. However, other studies have been done in which MPH has been given to people with neurodegenerative dementias and results have shown some improvement in these people's mood and cognition. Investigators would like to see if MPH will help mood and cognition. This study will take place completely virtually (with the option to come in for the first visit to meet the study team). All study visits will occur over a secure videoconferencing platform. All study materials will be shipped directly to the home of each participant.
Primary Outcome
To assess feasibility of this study design, completion rates of all study tasks and medication dosing will be evaluated. Benchmark goals for feasibility measures are set as follows: retain \>80% of participants enrolled, observe \>80% medication adherence, and \>80% outcome assessment completion rates.
Interventions
- OTHER Placebo
- DRUG Methylphenidate Extended Release Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-08-30 |
| Phase | Phase 4 |
What the finished NCT03811847 record still lists
NCT03811847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03811847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03811847 about?
NCT03811847 is a clinical study titled "A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.". Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment (MCI) or mild dementia likely due to Alzheimer's Disease (AD) and related disorders (ADRD). The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) t...
What is the current status of trial NCT03811847?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2019-11-01. Estimated completion is 2021-08-30.
What interventions are being tested in trial NCT03811847?
The interventions under investigation include: Placebo (OTHER), Methylphenidate Extended Release Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03811847?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03811847's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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