Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-06-30
2012-08-31
Brief Summary
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Detailed Description
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ADMET has 80% power to detect a difference of at least 3.3 in change in the Apathy Evaluation Scale scores between the two treatment groups. It also has 80% power to detect an absolute difference of 35% or more in the change in the proportion of study participants improving on te Clinical Global Impression of Change, given that 20% to 305 of participants in the placebo group show improvement.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Methylphenidate
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
Methylphenidate
The target dose is 20 mg per day provided as two 10 mg doses administered orally. Patients will start by taking 10 mg daily (two 5 mg over-encapsulated tablets) for three days, at which time the dose will be increased to 20 mg per day (four 5 mg over-encapsulated tablets). In the event of significant side-effects, the dose will be reduced to a minimum of 10 mg per day. The study drug will be administered for 6 weeks.
Psychosocial intervention
The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises.
The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements:
* Review and adjustment of the patient and caregiver supportive care plans
* Emotional support and opportunity to ventilate feelings
* Counseling regarding specific caregiving skills
* Assistance with problem solving of specific issues that the caregiver brings to the sessions
* Answers for questions regarding the educational materials
The educational materials will consist of a copy of the book The 36-Hour Day
Placebo
matching placebo and psychosocial intervention
placebo
Patients will start with two capsules of placebo for three days, at which time the dose will be increased to four capsules. The dose may be reduced to a minimum of two capsules per day if there appears to be significant side-effects. Placebo will be administered for 6 weeks.
Psychosocial intervention
The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises.
The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements:
* Review and adjustment of the patient and caregiver supportive care plans
* Emotional support and opportunity to ventilate feelings
* Counseling regarding specific caregiving skills
* Assistance with problem solving of specific issues that the caregiver brings to the sessions
* Answers for questions regarding the educational materials
The educational materials will consist of a copy of the book The 36-Hour Day
Interventions
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Methylphenidate
The target dose is 20 mg per day provided as two 10 mg doses administered orally. Patients will start by taking 10 mg daily (two 5 mg over-encapsulated tablets) for three days, at which time the dose will be increased to 20 mg per day (four 5 mg over-encapsulated tablets). In the event of significant side-effects, the dose will be reduced to a minimum of 10 mg per day. The study drug will be administered for 6 weeks.
placebo
Patients will start with two capsules of placebo for three days, at which time the dose will be increased to four capsules. The dose may be reduced to a minimum of two capsules per day if there appears to be significant side-effects. Placebo will be administered for 6 weeks.
Psychosocial intervention
The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises.
The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements:
* Review and adjustment of the patient and caregiver supportive care plans
* Emotional support and opportunity to ventilate feelings
* Counseling regarding specific caregiving skills
* Assistance with problem solving of specific issues that the caregiver brings to the sessions
* Answers for questions regarding the educational materials
The educational materials will consist of a copy of the book The 36-Hour Day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinically significant apathy for at least four weeks for which either 1) the frequency of apathy as assessed by the Neuropsychiatric Inventory (NPI) is 'Very frequently', or 2) 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 patient or surrogate (if the patient is unable to provide informed consent) and caregiver
* Availability of primary caregiver, who spends greater than ten hours a week with the patient and supervises his/her care, to accompany the patient to study visits and to participate in the study
* Sufficient fluency, of both the patient and caregiver, in written and spoken English to participate in study visits, physical exams, and outcome assessments
* No change to AD medications within the month preceding randomization, including starting, stopping, or dosage modifications
* Treatment with stable doses of selective serotonin reuptake inhibitor antidepressants(SSRIs) is appropriate if stable for 3 months prior to randomization. Other psychotropics(with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis.
Exclusion Criteria
* Clinically significant agitation /aggression for which either 1) the frequency of agitation /aggression as assessed by the NPI is 'Very frequently', or 2) 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 1) the frequency of delusions as assessed by the NPI is 'Very frequently', or 2) 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 1) the frequency of hallucinations as assessed by the NPI is 'Very frequently', or 2) 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'
* Treatment with psychotropic medications in the 2 weeks prior to randomization with the exception of approved treatments for dementia (ChEIs and memantine), selective serotonin reuptake inhibitor antidepressants, and trazodone (if used as an aid to facilitate sleep and not as an antidepressant); other psychotropics (with the exclusion of antipsychotics), if stable for 3 months, may be allowed only with Steering Committee approval on a case by case basis. Note that antipsychotics are expressly prohibited.
* Treatment with methylphenidate is contraindicated in the opinion of the study physician
* Failure of treatment with methylphenidate in the past for apathy after convincing evidence of an adequate trial as judged by study physician
* Treatment with a medication that would prohibit the safe concurrent use of methylphenidate such as monoamine oxidase inhibitors and tricyclic antidepressants
* Need for acute psychiatric hospitalization or is suicidal
* Uncontrolled hypertension (medication non-compliance or past 3 months with a diastolic reading of 105 as verified by compartment pressure of the rectus sheath (CPRS))
* Symptomatic coronary artery disease deemed to be significant by study physician at the time of screening
* Lack of appetite that results in significant unintentional weight loss as determined by the study physician in the last three months
* Significant communicative impairments
* Current participation in a clinical trial or in any study that may add significant burden or affect study outcomes
* Hyperthyroidism, advanced arteriosclerosis, symptomatic cardiovascular disease, serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or a family history of sudden death or death related to heart problems
* Glaucoma, pheochromocytoma, or known or suspected hypersensitivity to methylphenidate or its excipients
* Central Nervous System (CNS) abnormalities (e.g., cerebral aneurysm) and/or other vascular abnormalities such as vasculitis or pre-existing stroke, motor tics or a family history or diagnosis of Tourette's syndrome, seizures (convulsions, epilepsy), or abnormal EEGs
* Any condition that, in the opinion of the study physician, makes it medically inappropriate or risky for the patient to enroll in the trial
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Medical University of South Carolina
OTHER
Johns Hopkins University
OTHER
University of Toronto
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
Responsible Party
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Principal Investigators
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Roberta Scherer, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University Bloomberg School of Public Health
Jacobo Mintzer, MD, MBA
Role: STUDY_CHAIR
Medical University of South Carolina
Paul Rosenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Krista Lanctot, PhD
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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References
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Rosenberg PB, Lanctot KL, Drye LT, Herrmann N, Scherer RW, Bachman DL, Mintzer JE, ADMET Investigators. Safety and efficacy of methylphenidate for apathy in Alzheimer's disease: a randomized, placebo-controlled trial. J Clin Psychiatry. 2013 Aug;74(8):810-6. doi: 10.4088/JCP.12m08099.
Other Identifiers
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