CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Methylphenidate Extended Release Oral Capsule +1 moredrug
Likely dose
Methylphenidate Extended Release Oral Capsule 18mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03811847
NCT03811847Phase 4Completed

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

Massachusetts General Hospital·interventional·Posted Jan 22, 2019·Updated Jun 2, 2023

In Brief

A Phase 4 clinical trial evaluating Methylphenidate Extended Release Oral Capsule and Placebo for Alzheimer Dementia. Completed, enrolled 11 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJan 22, 2019
Enrollment StartNov 1, 2019
Primary CompletionAug 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.4 years ago

Interventions

Methylphenidate Extended Release Oral Capsuledrug

Stimulant It can treat ADHD and narcolepsy. 1 capsule 18mg

Placeboother

Placebo comparator MPH Matched Placebo Tablet