Start: January 2016
End: July 15, 2020
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?
- 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.
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?
Lead: Johns Hopkins Bloomberg School of Public Health
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT02346201