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

Primary Purpose

Diabetes Mellitus, Alzheimer's Disease, Apathy

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Methylphenidate

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes Mellitus, Alzheimer's Disease, Apathy, Methylphenidate, Dementia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Veterans Affairs Medical Center
University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylphenidate

Placebo

Arm Description

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

Standard inactive pill.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Apathy Evaluation Scale-Clinician (AES-C)

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.

Clinical Global Impression (CGI) Scale

Clinical Global Impression (CGI): This is an observational scale of global evaluation with two components-the CGI-Severity, which rates illness severity (1=normal, not at all ill to 7=among the most extremely ill patients) and the CGI-Improvement, which rates change from the initiation (baseline) of treatment (1=very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment.")

Instrumental Activities of Daily Living (IADL) Scale

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 (low functioning) to 23 (high functioning) based on the independent living of the patient.

Full Information

NCT ID

NCT00792662

First Posted

November 17, 2008

Last Updated

August 11, 2023

Sponsor

University of Nebraska

Collaborators

Alzheimer's Association

1. Study Identification

Unique Protocol Identification Number

NCT00792662

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

No Subjects enrolled

Study Start Date

November 18, 2008 (Actual)

Primary Completion Date

December 20, 2011 (Actual)

Study Completion Date

December 20, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

Collaborators

Alzheimer's Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Alzheimer's Disease, Apathy, Dementia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methylphenidate

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Standard inactive pill.

Intervention Type

Drug

Intervention Name(s)

Methylphenidate

Other Intervention Name(s)

Ritalin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

Standard inactive pill.

Primary Outcome Measure Information:

Title

Hemoglobin A1C as a Marker for Glycemic Control

Description

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 Measure Information:

Title

Apathy Evaluation Scale-Clinician (AES-C)

Description

Time Frame

16 weeks

Title

Clinical Global Impression (CGI) Scale

Description

Time Frame

16 weeks

Title

Instrumental Activities of Daily Living (IADL) Scale

Description

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prasad R Padala, M.D.

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Affairs Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68105

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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