Try our beta test site
Trial record 1 of 1 for:    NCT02346201
Previous Study | Return to List | Next Study

Apathy in Dementia Methylphenidate Trial 2 (ADMET2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT02346201
First received: January 20, 2015
Last updated: February 20, 2017
Last verified: March 2016
  Purpose
Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) is a Phase III, placebo-controlled, masked, 6 month, 10-center randomized clinical trial sponsored by National Institutes of Aging involving 200 participants with Alzheimer's disease (AD). ADMET 2 is designed to examine the efficacy and safety of methylphenidate as treatment for clinically significant apathy in AD participants. ADMET 2 will enroll participants from real world settings such as outpatient, nursing home, and assisted living facilities and will examine the effects of methylphenidate on apathy and cognition. ADMET 2 will also conduct careful safety monitoring.

Condition Intervention Phase
Apathy
Alzheimer's Disease
Drug: Methylphenidate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Apathy in Dementia Methylphenidate Trial 2

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Neuropsychiatric Inventory (NPI) [ Time Frame: baseline to 6 months ]
    Mean difference in change from baseline to 6 months in the NPI apathy subscale scores as administered by certified personnel to the study caregiver

  • Clinical Global Impression of Change (CGIC) [ Time Frame: At month 6 ]
    Odds of having a given rating or better on the Alzheimer's Disease Cooperative Study-CGIC ratings at month 6 as evaluated by a study clinician who records his/her clinical impression of change from baseline on a seven-item scale


Estimated Enrollment: 200
Study Start Date: January 2016
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methylphenidate
Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), in 5 mg over-capsulated tablets, and psychosocial intervention
Drug: Methylphenidate
Two 5mg methylphenidate over-encapsulated drug taken twice a day for 6 months (total of 20 mg methylphenidate per day), and psychosocial intervention
Other Name: Ritalin
Placebo Comparator: Placebo
Matching over-encapsulated placebo and psychosocial intervention
Drug: Placebo
Two over-encapsulated placebo taken twice a day for 6 months and psychosocial intervention

Detailed Description:

ADMET 2 will examine in a masked, randomized trial the efficacy of methylphenidate for the treatment of clinically significant apathy in participants with Alzheimer's dementia. Efficacy will be assessed as the change in Neuropsychiatric Inventory Apathy subscale (NPI apathy) from baseline to 6 months and score on the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (CGIC) scale at 6 months.

ADMET 2 will also examine the safety of methylphenidate for the treatment of clinically significant apathy in participants with Alzheimer's disease by measuring vital signs, electrolyte panels, adverse event reports, and electrocardiograms. Safety will also be measured by examining neuropsychiatric symptoms other than apathy using the Neuropsychiatric Inventory (NPI).

Changes from baseline to 6 months in other neuropsychological assessments as measured using the Dementia Apathy Interview and Rating (DAIR) scale will also be assessed.

Cost-effectiveness will be measured by assessing quality of life and economic assessment and cognitive changes using a cognitive battery that includes the Mini Mental State Exam (MMSE) and other scales.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 10-28 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02346201

Contacts
Contact: Roberta W Scherer, PhD rschere1@jhu.edu
Contact: Jennifer Jones jejones@jhu.edu

Locations
United States, Arizona
Banner Alzheimer's Institute Active, not recruiting
Phoenix, Arizona, United States, 85006
United States, Arkansas
University of Arkansas Recruiting
Little Rock, Arkansas, United States, 72114
Contact: Prasad Padala, MD       PPadala@uams.edu   
United States, Connecticut
Yale Alzheimer's Disease Research Unit Recruiting
New Haven, Connecticut, United States, 06510
Contact: Christopher van Dyck, MD       christopher.vandyck@yale.edu   
United States, Georgia
Emory Recruiting
Altanta, Georgia, United States, 30322
Contact: Allan Levey, MD       alevey@emory.edu   
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Sarah Woody, MS    410-550-9020    swoody1@jhmi.edu   
Principal Investigator: Paul Rosenberg, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14620
Contact: Anton Porsteinsson, MD       Anton_Porsteinsson@URMC.Rochester.edu   
United States, North Carolina
Wake Forest Recruiting
Winston-Salem, North Carolina, United States, 27106
Contact: Suzanne Craft, MD       suzcraft@wakehealth.edu   
United States, Ohio
University Hospitals- Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Alan Lerner, MD       ajl3@case.edu   
United States, South Carolina
Roper-St. Francis Healthcare Recruiting
Charleston, South Carolina, United States, 29401
Contact: Courtney O'Neill, MHA    843-724-2302    courtney.oneill@rsfh.com   
Principal Investigator: Olga Mintzer         
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Abby Li    (416) 480-6100 ext 3185    Abby.Li@sunnybrook.ca   
Principal Investigator: Krista Lanctot, PhD         
Sub-Investigator: Nathan Herrmann, MD         
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute on Aging (NIA)
Investigators
Study Chair: Jacobo Mintzer, MD Medical University of South Carolina
  More Information

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02346201     History of Changes
Other Study ID Numbers: ADMET2
R01AG046543 ( US NIH Grant/Contract Award Number )
Study First Received: January 20, 2015
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on March 24, 2017