DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Apathy in Dementia Methylphenidate Trial (ADMET)

Information source: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Apathy; Alzheimer's Disease

Intervention: Methylphenidate (Drug); placebo (Drug); Psychosocial intervention (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Roberta Scherer, PhD, Principal Investigator, Affiliation: Johns Hopkins University Bloomberg School of Public Health
Jacobo Mintzer, MD, MBA, Study Chair, Affiliation: Medical University of South Carolina
Paul Rosenberg, MD, Principal Investigator, Affiliation: Johns Hopkins University
Krista Lanctot, PhD, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre

Summary

The Apathy in Dementia Methylphenidate Trial (ADMET) is a masked, placebo-controlled trial that will examine the efficacy and safety of methylphenidate for the treatment of clinically significant apathy in patients with Alzheimer's dementia.

Clinical Details

Official title: Apathy in Dementia Methylphenidate Trial (ADMET)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Apathy Evaluation Scale (AES)

Alzheimer's Disease Cooperative Study- Clinical Global Impression of Change

Secondary outcome:

Digit Span

Mini-Mental State Exam (MMSE)

Neuropsychiatric Inventory (NPI): Apathy Subscale

Vital Status

Electrolytes

Electrocardiogram (ECG)

Detailed description: The Apathy in Dementia Methylphenidate Trial (ADMET), funded by the National Institute of Aging, is a Phase II, placebo-controlled, masked, 3-center randomized clinical trial. ADMET will enroll 60 patients with Alzheimer's disease (AD) and significant apathy from outpatient, nursing home, and assisted living facilities along with their primary caregiver. Eligible and willing patients will be randomly assigned to methylphenidate (20 mg per day) or placebo. At baseline and each in-person follow-up visit, all caregivers and patients will be provided with a standardized psychosocial intervention consisting of a counseling session, provision of educational materials, and 24-hour availability for crises. Efficacy and safety outcomes will be measured at baseline and at in-person follow-up visits at 2, 4, and 6 weeks following randomization. Telephone contact will take place at 1, 3, and 5 weeks after randomization. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 10-26 inclusive; MMSE scores above 26 in those who nevertheless meet criteria for AD may be allowed with Steering Committee approval on a case by case basis

- 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:

- Meets criteria for Major Depressive Episode, by Diagnostic Statistical Manual of

Mental Disorder - IV (TR) 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

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21224, United States

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Medical University of South Carolina, Charleston, South Carolina 29406, United States

Additional Information

ADMET website

Starting date: June 2010
Last updated: April 1, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017