Methylphenidate for Apathy in Alzheimer's Dementia: A Controlled Study
Condition: Alzheimer's Disease; Apathy; Dementia
MeSH terms: Alzheimer Disease; Dementia
Intervention: Methylphenidate; Placebo
Intervention description: Subject will receive 5mg twice a day for two weeks then 10mg twice a day until week 12 of the study.; Standard inactive pill.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Apathy; Dementia; Methylphenidate

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.
    

Eligibility 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