A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants.
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|ClinicalTrials.gov Identifier: NCT03811847|
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : September 4, 2019
Investigators are doing this research study to find out if methylphenidate (MPH) can help people with Mild Cognitive Impairment or mild dementia likely due to Alzheimer's Disease.
The study drug MPH is approved by the U.S. Food and Drug Administration (FDA) to treat Attention Deficit/Hyperactivity Disorder, 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 your mood and cognition.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Dementia||Drug: Methylphenidate Extended Release Oral Capsule Other: Placebo||Phase 4|
Investigators will give participants a supply of study drug to take home with participants. 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 your next visit, along with a few extra capsules as back up. Participants will be asked to bring any unused study drug with you to your next study visit.
Your Weekly Tasks During the study, Investigators will ask you to do certain tasks each week.
You will have to do the following tasks each day throughout the study:
- Wear your Fitbit activity tracker
- Take your study medication
Six Days per Week:
We will ask you to do the following tasks six days per week:
Complete Lumosity cognitive games
o Use Lumosity to rate your daily mood and sleep quality
- Synchronize your Fitbit to your study provided iPad tablet
Once every five days:
Investigators will ask you to do the following approximately every five days throughout the trial:
• Charge your Fitbit during a time when you are resting but not sleeping (such as while you are watching TV or reading). Investigators can help remind you to charge your Fitbit if you would like a reminder phone call.
The study coordinator will periodically log into both your Fitbit dashboard and your Lumosity account to check the battery level of your Fitbit, ensure your Fitbit is synching to the Fitbit dashboard, and monitor the completion of Lumosity cognitive exercises.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Estimated Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||January 30, 2021|
|Estimated Study Completion Date :||January 30, 2021|
During this study you will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. We will not reveal which you are taking at a given time until the end of the study.
Drug: Methylphenidate Extended Release Oral Capsule
Stimulant It can treat ADHD and narcolepsy.
Other Name: Ritalin
Placebo Comparator: Placebo
During this study you will get both the study drug Methylphenidate Extended Release Capsule and the placebo in random order. We will not reveal which you are taking at a given time until the end of the study. We are using the placebo in this study to compare if any improvements in your cognition are due to the study drug or due to other reasons.
- Cognition as measured by Lumosity Games [ Time Frame: 4 months ]We are investigating Methylphenidate to see if it will help improve cognition in adults with Alzheimer's Disease. Investigators are asking subjects to play cognitive games on an Ipad Tablet. Investigators expect to see a change in score.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811847
|Contact: Libby Desruisseauxemail@example.com|
|United States, Massachusetts|
|Clinical Translational Research Unit||Recruiting|
|Charlestown, Massachusetts, United States, 02124|
|Contact: Jessica Gerber 617-724-1992 firstname.lastname@example.org|
|Principal Investigator:||Steven E Arnold||MGH|