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WithdrawnPhase 4

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

Asset

Methylphenidate

Listed sites

0

Recruiting sites

-

Enrollment

-

actual

Study population

Alzheimer’s disease

Key I/E criteria

mild-to-moderate AD / moderate AD dementiaMMSE 18-29AD symptomatic therapy: stable

Primary endpoint

Hemoglobin A1C as a Marker for Glycemic Control

Identifiers

Registered as

Org study ID0470-08-FB
NCT IDNCT00792662

Timeline

Milestones

Study first posted2008-11-18estimated
Study start2008-11-18actual
Primary completion2011-12-20actual
Study completion2011-12-20actual
Last update posted2024-09-23actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years
SexAll
Healthy volunteersNot accepted

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
Behavior / neuropsychiatric
1
Other clinical outcomes
1
Other (unclassified)
1

Function / daily living

1 endpoint
Secondary/protocol endpoint

Instrumental Activities of Daily Living (IADL) Scale

Time frame:16 weeks

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Apathy Evaluation Scale-Clinician (AES-C)

Time frame:16 weeks

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Clinical Global Impression (CGI) Scale

Time frame:16 weeks

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Hemoglobin A1C as a Marker for Glycemic Control

Time frame:16 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.