Diabetes MellitusPhase 4NCT00792662
Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
A Phase 4 study testing Methylphenidate in people with Diabetes Mellitus and Alzheimer's Disease, run by University of Nebraska.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus, Alzheimer's Disease, Apathy
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2008to 20 Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
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- 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
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Alzheimer's Disease, Apathy, Dementia
- Being tested
- Methylphenidate, Placebo
- Keywords
- Diabetes Mellitus, Alzheimer's Disease, Apathy, Methylphenidate, Dementia
- Medical subject headings
- Diabetes Mellitus, Alzheimer Disease, Lethargy, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study.
PlaceboDrug
Also called Sugar Pill
Standard inactive pill.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Subject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study. Receives: Drug: Methylphenidate |
| Placebo | Placebo comparator | Standard inactive pill. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (3)
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.
Measured: 16 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.")
Measured: 16 weeks
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study start18 Nov 2008
- Primary completion20 Dec 2011
- Study completion20 Dec 2011
Why it stopped: No Subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Prasad R Padala, M.D., Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792662
- Sponsor's protocol ID
- 0470-08-FB
- Status last verified
- Sep 2024
- First submitted
- 17 Nov 2008
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
- ClinicalTrials.gov ID
- NCT00792662
- Acronym / sponsor ID
- 0470-08-FB
- Conditions
- Diabetes Mellitus, Alzheimer's Disease, Apathy, Dementia
- Keywords
- Diabetes Mellitus, Alzheimer's Disease, Apathy, Methylphenidate, Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 18 Nov 2008 (actual)
- Primary completion
- 20 Dec 2011 (actual)
- Study completion
- 20 Dec 2011 (actual)
- First posted
- 18 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: MethylphenidateSubject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study. |
| Placebo | Placebo comparator | Drug: PlaceboStandard inactive pill. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: RitalinSubject will receive 5mg BID for the first two weeks then 10mg BID until week 16 of the study. | Drug | Methylphenidate |
| PlaceboAlso: Sugar PillStandard inactive pill. | Drug | Placebo |
Primary outcome
Hemoglobin A1C as a Marker for Glycemic Control
Time frame: 16 weeks
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.
3 secondary outcomes
Apathy Evaluation Scale-Clinician (AES-C)
Time frame: 16 weeks
Clinical Global Impression (CGI) Scale
Time frame: 16 weeks
Instrumental Activities of Daily Living (IADL) Scale
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasad R Padala, M.D. principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Diabetes Mellitus and Alzheimer's Disease, run by University of Nebraska.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C as a Marker for Glycemic Control (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.