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

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: Alzheimer's Association
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. Diagnosis of dementia of the Alzheimer type (Diagnostic and Statistical Manual-IV Text Revision (DSM-IV TR) criteria)

2. Diagnoses of diabetes mellitus type II

3. Poor glycemic control (Hemoglobin A1c (HbA1c ≥ 7.0%))

4. Mild to Moderate Alzheimer's dementia (Mini Mental State Examination (MMSE) >18, but <29)

5. Apathy Evaluation Scale (AES) score of more than 30

6. Ability to provide informed consent by either the patient or caregiver.

7. 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.

8. 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.

9. Subjects should be on stable dose of statins and ACE inhibitors for ≥ 2 months.

10. Subjects should be on stable dose of diabetes treatment for 2 months prior to enrollment.

Exclusion Criteria:

1. Severe dementia (MMSE < 18)

2. Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.

3. Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.

4. Uncontrolled hypertension (BP > 140/90) or tachycardia (100) at screening visit

5. Patients with frontotemporal dementia

6. Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)

7. Patients with active psychosis as determined by MINI

8. Patients currently being treated with antipsychotics

9. History of uncontrolled seizure disorder

10. History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.

11. History of Tourette's syndrome or presence of motor tics

12. Patients with glaucoma

13. Patients taking monoamine oxidase inhibitors (MAOIs)

14. Patient taking clonidine

15. Patients being treated with insulin pump