Status:
WITHDRAWN
Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
Alzheimer's Association
Conditions:
Diabetes Mellitus
Alzheimer's Disease
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief 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 seco...
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 o...
Eligibility Criteria
Inclusion
- Diagnosis of dementia of the Alzheimer type (Diagnostic and Statistical Manual-IV Text Revision (DSM-IV TR) criteria)
- Diagnoses of diabetes mellitus type II
- Poor glycemic control (Hemoglobin A1c (HbA1c ≥ 7.0%))
- Mild to Moderate Alzheimer's dementia (Mini Mental State Examination (MMSE) \>18, but \<29)
- Apathy Evaluation Scale (AES) score of more than 30
- Ability to provide informed consent by either the patient or caregiver.
- If subjects are being treated with antidepressants, they should be on a stable dose of antidepressants for at least two months prior to the enrollment into the study.
- If subjects are being treated with cholinesterase inhibitors and memantine, they should be on stable dose of those medications at least four months prior to the enrollment into the study.
- Subjects should be on stable dose of statins and ACE inhibitors for ≥ 2 months.
- Subjects should be on stable dose of diabetes treatment for 2 months prior to enrollment.
Exclusion
- Severe dementia (MMSE \< 18)
- Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.
- Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.
- Uncontrolled hypertension (BP \> 140/90) or tachycardia (100) at screening visit
- Patients with frontotemporal dementia
- Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)
- Patients with active psychosis as determined by MINI
- Patients currently being treated with antipsychotics
- History of uncontrolled seizure disorder
- History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.
- History of Tourette's syndrome or presence of motor tics
- Patients with glaucoma
- Patients taking monoamine oxidase inhibitors (MAOIs)
- Patient taking clonidine
- Patients being treated with insulin pump
Key Trial Info
Start Date :
November 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00792662
Start Date
November 18 2008
End Date
December 20 2011
Last Update
September 23 2024
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