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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by University of Nebraska.
Recruitment status was:  Recruiting
Alzheimer's Association
Information provided by:
University of Nebraska Identifier:
First received: November 17, 2008
Last updated: January 12, 2010
Last verified: January 2010
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.

Condition Intervention Phase
Diabetes Mellitus Alzheimer's Disease Apathy Dementia Drug: Methylphenidate Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Function, Quality of Life, Glycemia in Diabetics With Dementia

Resource links provided by NLM:

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Hemoglobin A1C (HbA1c) will be used as marker for glycemic control. It is accepted as the best marker for glycemic control in the previous 120 days. Changes in HbA1c are clinically meaningful. [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Apathy Evaluation Scale-Clinician (AES-C): The clinician-rated version will be used for this project. This 18 item scale with scores ranging from 18 to 72, assesses apathy in behavioral, cognitive and emotional domains over the previous four weeks. [ Time Frame: 16 weeks ]
  • Clinical Global Impression (CGI): This is an observational scale of global evaluation, which assesses the change in degree of illness in relation to the original assessment. [ Time Frame: 16 weeks ]
  • Instrumental Activities of Daily Living (IADL): It is a survey assessing eight domains of higher functions necessary to live independently. It is rated from 0-23 based on the independent living of the patient. [ Time Frame: 16 weeks ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate
Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
Drug: Methylphenidate
Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
Other Name: Ritalin
Placebo Comparator: Placebo
Standard inactive pill.
Drug: Placebo
Standard inactive pill.
Other Name: Sugar Pill

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.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00792662

Contact: Daniel A Ramirez, B.S. 402-995-4036
Contact: Prasad R Padala, M.D. 402-995-3484

United States, Nebraska
Veterans Affairs Medical Center Recruiting
Omaha, Nebraska, United States, 68105
Contact: Prasad Padala, MD    402-995-3484   
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Prasad R Padala, M.D.         
Sponsors and Collaborators
University of Nebraska
Alzheimer's Association
Principal Investigator: Prasad R Padala, M.D. University of Nebraska
  More Information

Responsible Party: Prasad R. Padala, M.D., University of Nebraska Medical Center Identifier: NCT00792662     History of Changes
Other Study ID Numbers: 470-08-FB
Study First Received: November 17, 2008
Last Updated: January 12, 2010

Keywords provided by University of Nebraska:
Diabetes Mellitus
Alzheimer's Disease

Additional relevant MeSH terms:
Diabetes Mellitus
Alzheimer Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on September 21, 2017