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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792662
Recruitment Status : Withdrawn (No Subjects enrolled)
First Posted : November 18, 2008
Last Update Posted : March 29, 2018
Alzheimer's Association
Information provided by (Responsible Party):
University of Nebraska

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Actual Study Start Date : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00792662

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United States, Nebraska
Veterans Affairs Medical Center
Omaha, Nebraska, United States, 68105
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Alzheimer's Association
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Principal Investigator: Prasad R Padala, M.D. University of Nebraska
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Responsible Party: University of Nebraska Identifier: NCT00792662    
Other Study ID Numbers: 470-08-FB
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Keywords provided by University of Nebraska:
Diabetes Mellitus
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Diabetes Mellitus
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