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Citalopram for the Treatment of Agitation in Alzheimer's Disease (CitAD)
This study is not yet open for participant recruitment.
Verified by National Institute on Aging (NIA), May 2009
First Received: May 11, 2009   No Changes Posted
Sponsor: National Institute on Aging (NIA)
Collaborator: National Institute of Mental Health (NIMH)
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00898807
  Purpose

The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.


Condition Intervention Phase
Alzheimer's Disease
Agitation
Drug: citalopram
Drug: placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • NeuroBehavior Rating Scale [ Time Frame: every 3 weeks over 9 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alzheimer's Disease Cooperative Study-Clinical Global Impression Of Change (ADCS-CGIC), modified [ Time Frame: every 3 weeks over 9 weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: every 3 weeks over 9 weeks ] [ Designated as safety issue: No ]
  • Udvalg for Kliniske Undersogelser (UKU) side effects rating scale [ Time Frame: every 3 weeks over 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: citalopram
target dose 30mg daily for 9 weeks
2: Placebo Comparator Drug: placebo
daily for 9 weeks

Detailed Description:

This study is designed to examine the efficacy and safety of citalopram as treatment for clinically significant agitation in Alzheimer's dementia (AD) patients. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. The management of agitation is a major priority in treating patients with AD. Non-pharmacologic options have limited effectiveness. Several pharmacologic options have been explored, but findings for anticonvulsants, antipsychotics, and cholinesterase inhibitors are disappointing or associated with questionable risk-benefit ratio. Better pharmacologic options are needed. Selective serotonin reuptake inhibitors (SSRIs) show promise as a treatment for agitation in AD, based on evidence of a link between agitation and brain serotonin system abnormalities in AD patients, and on preliminary clinical data from a single-site, randomized controlled trial (RCT) in which citalopram was superior to perphenazine and placebo.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Probable Alzheimer's disease (NINCDS-ADRDA criteria), with MMSE score of 5-26 inclusive
  • Clinically significant agitation for which 1) a medication is needed; 2) score ≥ 4 on the Neuropsychiatric Inventory (NPI) agitation domain; 3) more than 2 agitated behaviors per week as assessed on the NPI
  • Availability of primary caregiver, who spends several 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 the patient and caregiver, in written and spoken English or Spanish to participate in study visits, neuropsychological testing, and other outcome assessments
  • Stable treatment for AD with cholinesterase inhibitors and/or memantine

Exclusion Criteria:

  • Meets criteria for Major Depressive Episode by DSM-IV criteria
  • Presence of a brain disease that might otherwise fully explain the presence of dementia, such as extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis
  • Psychosis (delusions or hallucinations) requiring antipsychotic treatment in the opinion of the study physician
  • Treatment with citalopram is contraindicated
  • Failure of past treatment with citalopram for agitation after adequate trial at a minimally accepted dose (greater than or equal to 20mg/day)
  • Treatment with a medication that would prohibit the safe concurrent use of citalopram, such as MAO inhibitors
  • Need for psychiatric hospitalization, or acutely suicidal
  • Current participation in a clinical trial or in any study that may add a significant burden or affect neuropsychological or other study outcomes
  • Current treatment with antipsychotics, anticonvulsants, other antidepressants (other than trazodone, less than or equal to 50 mg per day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants
  • Any condition that makes it medically inappropriate or risky for the patient to enroll in the trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898807

Contacts
Contact: Kristine Boehmer 410-550-9024 khalter1@jhmi.edu

Locations
United States, California
University of Southern California Keck School of Medicine Memory and Aging Center
Los Angeles, California, United States, 90089
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, New York
Monroe Community Hospital
Rochester, New York, United States, 14559
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania, Section of Geriatric Psychiatry, Ralston House
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina Alzheimer's Research and Clinical Programs
Charleston, South Carolina, United States, 29406
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J1H4
Sponsors and Collaborators
Investigators
Principal Investigator: Constantine Lyketsos, MD, MHS Johns Hopkins University
Study Director: Lon Schneider, MD University of Southern California Keck School of Medicine Memory and Aging Center
Study Director: Bruce Pollock, MD Centre for Addiction and Mental Health
Study Director: Jacobo Mintzer, MD Medical University of South Carolina Alzheimer's Research and Clinical Programs
Study Director: Curtis Meinert, PhD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University ( Constantine Lyketsos, MD, MHS )
Study ID Numbers: IA0155, R01AG031348
Study First Received: May 11, 2009
Last Updated: May 11, 2009
ClinicalTrials.gov Identifier: NCT00898807     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
BPSD
neuropsychiatric symptoms
aggression
mood lability

Additional relevant MeSH terms:
Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Psychomotor Agitation
Cholinergic Agents
Neurodegenerative Diseases
Brain Diseases
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Psychomotor Disorders
Dementia
Dexetimide
Antidepressive Agents, Second-Generation
Neurobehavioral Manifestations
Antidepressive Agents
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Dyskinesias
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists

ClinicalTrials.gov processed this record on November 05, 2009