Phase
Condition
Alzheimer's Disease
Dementia
Memory Loss
Treatment
Methylphenidate
Placebo
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion criteria
Possible or probable Alzheimer's disease (National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria), with Mini-Mental State Exam (MMSE) score of 10-28 inclusive
Clinically significant apathy for at least four weeks for which either
the frequency of apathy as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or
the frequency of apathy as assessed by the NPI is 'Frequently' or 'Often' AND the severity of apathy as assessed by the NPI is 'Moderate' or 'Marked'
A medication for apathy is appropriate, in the opinion of the study physician
Provision of informed consent for participation in the study by potential participant or surrogate (with participant assent if the potential participant is unable to provide informed consent) and caregiver
Availability of primary caregiver, who spends greater than ten hours a week with the potential participant and supervises his/her care, to accompany the potential participant to study visits and to participate in the study
Sufficient fluency, of both the potential participant and caregiver, in written and spoken English to participate in study visits, physical exams, and outcome assessments
If female, woman must be post-menopausal for at least 2 years or have had a hysterectomy
Exclusion criteria
Currently meets criteria for Major Depressive Episode, by Diagnostic Statistical Manual of Mental Disorder - IV (TR) criteria
Clinically significant agitation /aggression for which either
the frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or
the frequency of agitation /aggression as assessed by the NPI is 'Frequently' AND the severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'
Clinically significant delusions for which either
the frequency of delusions as assessed by the NPI is 'Very frequently', or
the frequency of delusions as assessed by the NPI is 'Frequently' AND the severity of the delusions as assessed by the NPI is 'Moderate', or 'Marked'
Clinically significant hallucinations for which either
the frequency of hallucinations as assessed by the NPI is 'Very frequently', or
the frequency of hallucinations as assessed by the NPI is 'Frequently' AND the severity of the hallucinations as assessed by the NPI is 'Moderate', or 'Marked'
Change to AD medications within the month preceding randomization, including starting, stopping, or dosage modifications
Change in anti-depressant (except for trazodone used for sleeping difficulties as described below) use within the 30 days preceding randomization or a period of time equal to 5 half-lives of drug, whichever period of time is longer
Use of trazodone > 50mg or lorazepam > 0.5mg or for indications other than sleeping difficulties within the 30 days preceding randomization or a period of time equal to 5 half-lives of drug, whichever period of time is longer. Other benzodiazepines are prohibited in the past 30 days or within 5 half-lives, whichever period of time is longer.
Failure of treatment with methylphenidate in the past for apathy after convincing evidence of an adequate trial as judged by study physician
Currently taking any amphetamine product, an antipsychotic, bupropion, or any medication that would prohibit the safe concurrent use of methylphenidate, including but not limited to monoamine oxidase inhibitors and tricyclic antidepressants within the 30 days preceding randomization or a period of time equal to 5 half-lives of drug, whichever period of time is longer
Need for acute psychiatric hospitalization or is suicidal in the opinion of the study physician
Significant communicative impairments that would affect participation in clinical trial
Central nervous system abnormalities (e.g., cerebral aneurysm), seizures (convulsions, epilepsy), Tourette's syndrome or presence of motor tics, or abnormal electroencephalograms
Lack of appetite that results in significant unintentional weight loss as determined by the study physician in the last three months
Uncontrolled hyperthyroidism
Any cardiovascular or cerebrovascular abnormality deemed to be clinically significant by the study physician, tachycardia (heart rate > 100 beats per minute), or uncontrolled hypertension (defined as medication non-compliance or past 3 months with a diastolic reading > 105 mm Hg), at the time of screening
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, in the opinion of the study physician, makes it medically inappropriate or risky for the potential participant to enroll in the trial, including, but not limited to, contraindication to treatment with methylphenidate.
Study Design
Study Description
Connect with a study center
Sunnybrook Health Sciences Centre
Toronto, Ontario
CanadaSite Not Available
Banner Alzheimer's Institute
Phoenix, Arizona 85006
United StatesSite Not Available
University of Arkansas
Little Rock, Arkansas 72114
United StatesSite Not Available
Yale Alzheimer's Disease Research Unit
New Haven, Connecticut 06510
United StatesSite Not Available
Emory
Altanta, Georgia 30322
United StatesSite Not Available
Emory
Atlanta, Georgia 30322
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21224
United StatesSite Not Available
University of Rochester
Rochester, New York 14620
United StatesSite Not Available
Wake Forest
Winston-Salem, North Carolina 27106
United StatesSite Not Available
University Hospitals- Case Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Roper-St. Francis Healthcare
Charleston, South Carolina 29401
United StatesSite Not Available
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