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Apathy in Dementia Methylphenidate Trial 2 (ADMET 2)

Start: January 2016
End: July 15, 2020
Enrollment: 200

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: N/A

Maximum Age: N/A

Must have:

  • 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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: Johns Hopkins Bloomberg School of Public Health

Collaborator Sponsor

  • National Institute on Aging (NIA)

Source: ClinicalTrials.gov ID: NCT02346201