NCT03811847

A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators will give participants a supply of study drug. Participants will take the study drug by mouth once a day for 16 weeks. It is important for participants to follow our instructions about how to take the study drug. Participants can take the drug with or without food. Investigators will provide enough study drug for participants to take until the next visit. For this study, there are 3 blocks: each month-long block will consist of MPH for a two-week period (I.e. "A" Blocks 1, 2, 3) and PBO for a two-week period (I.e. "B" Blocks 1, 2, 3) in random assignment order for each block. Thus, all volunteers will receive a four-week PBO-lead in and acclimatization followed by treatment with MPH or matching PBO for eight-weeks each in three randomized sequence crossover blocks for a total of 10 weeks of PBO and 6 weeks of MPH. Weekly Tasks During the study, certain tasks must be done each week. Every Day: The following tasks must be done each day throughout the study: * Wear the activity tracker * Take study medication Six Days per Week: The following tasks will be completed six days per week: * Complete online cognitive games o Use online brain games to rate daily mood and sleep quality * Synchronize Fitness tracker to study provided tablet (if requested) Once every five days: The following activities must be done approximately every five days throughout the trial: • Charge Fitness tracker during a time when the subject is resting but not sleeping The study coordinator will periodically log into both the Fitness tracker dashboard and the online brain game account to check the battery level of the Fitness tracker, ensure the Fitness tracker is synching to the Fitness tracker dashboard, and monitor the completion of cognitive exercises.

Conditions

• Alzheimer Dementia

Interventions

Type	Name	Description
DRUG	Methylphenidate Extended Release Oral Capsule	Stimulant It can treat ADHD and narcolepsy. 1 capsule 18mg
OTHER	Placebo	Placebo comparator MPH Matched Placebo Tablet

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2019-01-22
• Last updated: 2023-06-02
• Results posted: 2023-06-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study