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Apathy in Dementia Methylphenidate Trial 2 (ADMET 2)

Completed

ADMET 2 will test methylphenidate (Ritalin), a drug approved to treat symptoms of attention deficit hyperactivity disorder and narcolepsy, as treatment for clinically significant apathy in people with Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
N/A N/A All No
January 2016
July 15, 2020
200

  • Possible or probable Alzheimer's disease
  • Mini-Mental State Examination (MMSE) score of 10-28 inclusive
  • Clinically significant apathy for at least 4 weeks
  • Informed consent for participation in the study by participant or surrogate and caregiver
  • Availability of primary caregiver who spends more than 10 hours/week with participant to accompany participant to study visits and to participate in the study
  • Sufficient fluency in written and spoken English to participate in study visits, physical exams, and outcome assessments
  • Females must be postmenopausal for at least 2 years or have had a hysterectomy

  • Currently meets criteria for major depressive episode
  • Clinically significant agitation /aggression
  • Clinically significant delusions
  • Clinically significant hallucinations
  • Change in Alzheimer's medications within the month preceding randomization, including starting, stopping, or dosage modifications
  • Change in antidepressant use (except for trazodone used for sleeping difficulties) within 30 days before randomization or a period of time equal to 5 half-lives of the drug, whichever is longer
  • Use of trazodone >50 mg or lorazepam >0.5mg for indications other than sleeping difficulties within 30 days before randomization or a period of time equal to 5 half-lives of the drug, whichever is longer; similar use of other benzodiazepines
  • Failure of treatment with methylphenidate for apathy in the past
  • Prohibited medications: any amphetamine, antipsychotic, bupropion, or other medication that would prohibit taking methylphenidate, including but not limited to monoamine oxidase inhibitors and tricyclic antidepressants
  • Need for acute psychiatric hospitalization or suicidal
  • Significant communication impairments
  • Central nervous system abnormalities (such as cerebral aneurysm), seizures (convulsions, epilepsy), Tourette's syndrome; presence of motor tics or abnormal electroencephalograms
  • Lack of appetite that resulted in significant, unintentional weight loss in the last 3 months
  • Uncontrolled hyperthyroidism
  • Any cardiovascular or cerebrovascular abnormality deemed to be clinically significant, tachycardia (heart rate >100 beats/minute), or uncontrolled hypertension
  • Closed angle glaucoma or pheochromocytoma
  • Women with childbearing potential
  • Current participation in a clinical trial or study that may add significant burden or affect study outcomes
  • Any condition that makes it medically inappropriate or risky to enroll in the trial, including contraindication to methylphenidate

This is a Phase III clinical trial designed to test methylphenidate (Ritalin) as treatment for clinically significant apathy in people with Alzheimer's disease. Methylphenidate is a drug approved to treat symptoms of attention deficit hyperactivity disorder and narcolepsy, a sleep disorder. Participants will come from real-world settings such as outpatient clinics, nursing homes, and assisted living facilities.

Participants with Alzheimer's dementia will be randomly assigned to take either methylphenidate or a placebo for 6 months (10 mg twice per day). The study drug's safety and efficacy will be assessed through neuropsychological tests that measure cognition, apathy, and other neuropsychiatric symptoms. Vital signs, electrolyte panels, adverse events, and electrocardiograms will also be monitored.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute
Phoenix Arizona 85006

University of Arkansas
Little Rock Arkansas 72114

Yale Alzheimer's Disease Research Unit
New Haven Connecticut 06510

Emory
Atlanta Georgia 30322

Johns Hopkins University
Baltimore Maryland 21224

University of Rochester
Rochester New York 14620

Wake Forest
Winston-Salem North Carolina 27106

University Hospitals- Case Medical Center
Cleveland Ohio 44106

Roper-St. Francis Healthcare
Charleston South Carolina 29401

Sunnybrook Health Sciences Centre
Toronto Ontario

Johns Hopkins Bloomberg School of Public Health

  • National Institute on Aging (NIA)

Name Role Affiliation
Jacobo Mintzer, MD Study Chair Medical University of South Carolina

Name Phone Email
Roberta W. Scherer, PhD rschere1@jhu.edu
Jennifer Jones jejones@jhu.edu

NCT02346201

Apathy in Dementia Methylphenidate Trial 2