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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Nebraska.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00792662
First received: November 17, 2008
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00792662

Contacts
Contact: Daniel A Ramirez, B.S. 402-995-4036 daniel.ramirez@va.gov
Contact: Prasad R Padala, M.D. 402-995-3484 ppadala@unmc.edu

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

No publications provided

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

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

Additional relevant MeSH terms:
Diabetes Mellitus
Alzheimer Disease
Dementia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014