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

University of Nebraska

Status and phase

Withdrawn

Phase 4

Conditions

Apathy

Alzheimer's Disease

Diabetes Mellitus

Dementia

Treatments

Drug: Placebo

Drug: Methylphenidate

Study type

Interventional

Funder types

Other

Identifiers

NCT00792662

0470-08-FB

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.
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 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
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