NCT00792662

Improving Function, Quality of Life, Glycemia in Diabetics With Dementia

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine if the study medication Methylphenidate (Ritalin) will improve subject's blood-sugar control by improving their motivation more than placebo. The secondary objectives of the study are to determine if daily functioning and quality of life improves with methylphenidate treatment.

Detailed description

A total of 50 subjects will be enrolled in this study. This study is being conducted at two sites, UNMC and the Omaha VA Medical Center. The subject will be asked to take the study drug in the form of a capsule to be taken twice daily. Whether the subject receives methylphenidate or placebo (a pill that has a similar appearance to the study drug, but has no medicine) will be determined by random chance. The probability that the subject will receive methylphenidate is 1 in every 2 subjects or 50% of the time. Subjects receiving methylphenidate will be starting at 5 milligrams (mg) twice daily. Dosage will then be increased to 10mg twice daily at 2 weeks. After the initial visits, the subjects will be asked to come for follow-up every month for the next 4 visits (sixteen weeks total). During each visit subjects will again be asked questions to assess their motivation, memory, functional status and quality of life. Blood will be drawn and an electrocardiogram (ecg/ekg) will be taken to assess the patient's safety twice during the study. Partial Compensation may be available for participation.

Conditions

• Diabetes Mellitus
• Alzheimer's Disease
• Apathy
• Dementia

Interventions

Type	Name	Description
DRUG	Methylphenidate	Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
DRUG	Placebo	Standard inactive pill.

Timeline

• Start date: 2008-11-18
• Primary completion: 2011-12-20
• Completion: 2011-12-20
• First posted: 2008-11-18
• Last updated: 2024-09-23