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

NCT00792662 | Withdrawn Phase 4 DMC

• 1 other identifier: 0470-08-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Alzheimer's Disease; Apathy; Dementia

Keywords

Diabetes Mellitus; Alzheimer's Disease; Apathy; Methylphenidate; Dementia

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C as a Marker for Glycemic Control

  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.

  16 weeks

Secondary Outcomes (3)

• Apathy Evaluation Scale-Clinician (AES-C)

  16 weeks

• Clinical Global Impression (CGI) Scale

  16 weeks

• Instrumental Activities of Daily Living (IADL) Scale

  16 weeks

Study Arms (2)

Methylphenidate

EXPERIMENTAL

Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Standard inactive pill.

Drug: Placebo

Interventions

Methylphenidate DRUG

Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.

Also known as: Ritalin

Methylphenidate

Placebo DRUG

Standard inactive pill.

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Alzheimer's Association: collaborator

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Lethargy; Dementia

Interventions

Methylphenidate; Sugars

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Prasad R Padala, M.D.

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 18, 2008
• Study Start: November 18, 2008
• Primary Completion: December 20, 2011
• Study Completion: December 20, 2011
• Last Updated: September 23, 2024

Record last verified: 2024-09