Phase 4 N=60 Randomized Triple-blind Treatment

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

Alzheimer's Disease · Apathy · Dementia

Bottom Line

View on ClinicalTrials.gov: NCT00495820 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Apathy Evaluation Scale Score at 12 Weeks — 38.2; 43.6 units on a scale — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Methylphenidate (Drug); Placebo (Other)
Age: Adult, Older Adult · 55+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Apathy Evaluation Scale Score at 12 Weeks	38.2; 43.6	<0.05 sig
SECONDARY Mini-mental State Examination (MMSE) at 12 Weeks	25.8; 23.6	=0.01 sig
SECONDARY Clinical Global Impression	3.9; 4.8	—

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

Diagnosis of dementia of the Alzheimer type (DSM-IV Text Revision (TR) criteria)
Mini-mental state examination (MMSE) >18, but 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)
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00495820). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.