Clinical trial NCT00792662: Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
Official title: Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Alzheimer's Disease
Apathy
Dementia
Keywords: Diabetes Mellitus
Alzheimer's Disease
Apathy
Methylphenidate
Dementia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2008-11-18
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Hemoglobin A1C as a Marker for Glycemic Control
timeFrame: 16 weeks
Secondary outcomes:
measure: Apathy Evaluation Scale-Clinician (AES-C)
timeFrame: 16 weeks
measure: Clinical Global Impression (CGI) Scale
timeFrame: 16 weeks
measure: Instrumental Activities of Daily Living (IADL) Scale
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Nebraska
name: Prasad R Padala, M.D.
role: PRINCIPAL_INVESTIGATOR
References: