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Improving Function, Quality of Life, Glycemia in Diabetics With Dementia
Lead sponsor
Asset
Methylphenidate
Listed sites
0
Recruiting sites
-
Enrollment
-
actual
Study population
Alzheimer’s disease
Key I/E criteria
•mild-to-moderate AD / moderate AD dementia•MMSE 18-29•AD symptomatic therapy: stable
Primary endpoint
•Hemoglobin A1C as a Marker for Glycemic Control
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Function / daily living
1 endpointInstrumental Activities of Daily Living (IADL) Scale
Time frame:16 weeks
descriptive
Behavior / neuropsychiatric
1 endpointApathy Evaluation Scale-Clinician (AES-C)
Time frame:16 weeks
descriptive
Other clinical outcomes
1 endpointClinical Global Impression (CGI) Scale
Time frame:16 weeks
descriptive
Other (unclassified)
1 endpointHemoglobin A1C as a Marker for Glycemic Control
Time frame:16 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.