Apathy in Dementia Methylphenidate Trial (ADMET)

Summary

The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial that will examine the efficacy and safety of methylphenidate for the treatment of clinically significant apathy in patients with Alzheimer's dementia.

Conditions

• Apathy
• Alzheimer's Disease

Interventions

DRUG

Methylphenidate

The target dose is 20 mg per day provided as two 10 mg doses administered orally. Patients will start by taking 10 mg daily (two 5 mg over-encapsulated tablets) for three days, at which time the dose will be increased to 20 mg per day (four 5 mg over-encapsulated tablets). In the event of significant side-effects, the dose will be reduced to a minimum of 10 mg per day. The study drug will be administered for 6 weeks.

DRUG

placebo

Patients will start with two capsules of placebo for three days, at which time the dose will be increased to four capsules. The dose may be reduced to a minimum of two capsules per day if there appears to be significant side-effects. Placebo will be administered for 6 weeks.

OTHER

Psychosocial intervention

The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises. The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements: * Review and adjustment of the patient and caregiver supportive care plans * Emotional support and opportunity to ventilate feelings * Counseling regarding specific caregiving skills * Assistance with problem solving of specific issues that the caregiver brings to the sessions * Answers for questions regarding the educational materials The educational materials will consist of a copy of the book The 36-Hour Day

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Medical University of South Carolina

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Roberta Scherer, PhD · Johns Hopkins University Bloomberg School of Public Health

• Jacobo Mintzer, MD, MBA · Medical University of South Carolina

• Paul Rosenberg, MD · Johns Hopkins University

• Krista Lanctot, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2012-08-31

Completion

2012-08-31

Countries

• United States
• Canada

Study Locations