Start:
January 2016
End:
July 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?
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
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?
Collaborator Sponsor
-
National Institute on Aging (NIA)
Source:
ClinicalTrials.gov ID:
NCT02346201