Improving Function, Quality of Life, Glycemia in Diabetics With Dementia (NCT00792662) | Clinical Trial Compass
WithdrawnPhase 4
Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
Stopped: No Subjects enrolled
0Started 2008-11-18
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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