Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the efficacy of methylphenidate over placebo in treating apathy in patients with Alzheimer's dementia. Apathy is one of the earliest and most profound disturbances that occur in Alzheimer's dementia (AD).

Hypotheses: 1. Methylphenidate (MPH) will improve apathy significantly more than placebo in AD.

2. Successful treatment of apathy will improve Instrumental Activities of Daily Living (IADLs), and caregiver burden.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

1. Diagnosis of dementia of the Alzheimer type (DSM-IV Text Revision (TR) criteria)

2. Mini-mental state examination (MMSE) >18, but <29

3. Apathy Evaluation Scale (AES) score of more than 40

4. Ability to provide informed consent by either the patient or caregiver.

5. 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.

6. 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.

Exclusion Criteria:

1. Patient currently taking methylphenidate or hypersensitivity or prior significant adverse events with methylphenidate.

2. Patients currently taking Adderall (amphetamine mixed salts) or Dexedrine (dextroamphetamine sulphate) or any other amphetamine product.

3. Uncontrolled hypertension (BP > 140/90) or tachycardia (100) at screening visit

4. Patients with frontotemporal dementia

5. Patients meeting criteria for Major Depressive Disorder on the Mini International Neuropsychiatric Inventory (MINI)

6. Patients with active psychosis as determined by MINI

7. Patients currently being treated with antipsychotics

8. History of uncontrolled seizure disorder

9. History of malignant hypertension, symptomatic cardiovascular disease, cardiomyopathy, known structural cardiac defect or medically unstable arrhythmias.

10. History of Tourette's syndrome or presence of motor tics

11. Patients with glaucoma

12. Patients taking monoamine oxidase inhibitors (MAOIs)

13. Patient taking clonidine