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

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.

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