Alzheimer's Disease Education and Referral Center

Citalopram for Agitation in Alzheimer's Disease (CitAD)

Citalopram for Agitation in Alzheimer's Disease (CitAD)

Overall Status: 
Completed
Brief Description: 

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

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
N/A
N/A
Both
No
Inclusion Criteria: 

  • Probable Alzheimer's disease (NINCDS-ADRDA criteria), with MMSE score of 5-28
  • Clinically significant agitation for which a medication is needed, individual has score ≥ 4 on the Neuropsychiatric Inventory (NPI) agitation domain, and more than two agitated behaviors per week
  • 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
  • Stable treatment for Alzheimer's disease with cholinesterase inhibitors and/or memantine

Exclusion Criteria: 

  • Major depression
  • Brain disease that might otherwise 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
  • Need for psychiatric hospitalization or acutely suicidal
  • Current participation in a clinical trial or any study that may add a significant burden or affect study outcomes
  • Any condition that makes it medically inappropriate or risky for the patient to enroll in the trial
  • Prohibited medications: Citalopram; failure of past treatment with citalopram for agitation after adequate trial at a minimally accepted dose (greater than or equal to 20 mg/day); any medication that would prohibit the safe concurrent use of citalopram, such as MAO inhibitors; current treatment with antipsychotics, anticonvulsants, other antidepressants (other than trazodone, less than or equal to 50 mg/day at bedtime), benzodiazepines (other than lorazepam), or psychostimulants

Detailed Description: 

This study is designed to examine the efficacy and safety of citalopram as treatment for significant agitation in people with Alzheimer's dementia. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. Citalopram is a selective serotonin reuptake inhibitor, a type of antidepressant.

The management of agitation is a major priority in treating people with Alzheimer's disease. 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 show promise as a treatment for agitation in Alzheimer's, based on evidence of a link between agitation and brain serotonin system abnormalities in people with the diseaseAD patients, and on preliminary clinical data from a single-site, randomized controlled trial in which citalopram was superior to perphenazine and placebo.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 34.0220127, -118.2892046

Site
Los Angeles
California
90089
Name:
Phone:

Geolocation is 37.3813444, -122.1802812

Site
Palo Alto
California
94304
Name:
Phone:

Geolocation is 39.2713976, -76.5603828

Site
Baltimore
Maryland
21224
Name:
Phone:

Geolocation is 40.8409822, -73.9447994

Site
New York
New York
10032
Name:
Phone:

Geolocation is 43.1961891, -77.8138553

Site
Rochester
New York
14559
Name:
Phone:

Geolocation is 39.9583587, -75.1953934

Site
Philadelphia
Pennsylvania
19104
Name:
Phone:

Geolocation is 32.9221152, -80.0367259

Site
Charleston
South Carolina
29406
Name:
Phone:

Geolocation is 43.6435768, -79.4176391

Site
Toronto
Ontario
M6J1H4
Name:
Phone:
Lead Sponsor: 
Agency
Johns Hopkins University
Collaborator Sponsor: 
Agency
National Institute on Aging (NIA)
National Institute of Mental Health (NIMH)
Facility Investigators: 
NameRoleAffiliation
Constantine Lyketsos, MD
Study Chair
Johns Hopkins University
Lon Schneider, MD
Study Director
University of Southern California Keck School of Medicine Memory and Aging Center
Bruce Pollock, MD
Study Director
Centre for Addiction and Mental Health
Jacobo Mintzer, MD
Study Director
Medical University of South Carolina Alzheimer's Research and Clinical Programs
David Shade, Esq
Study Director
Johns Hopkins University
Study Contact: 
NamePhone
Anne Roche
410-550-9024
Locations
 
 
ClinicalTrials.gov ID 
NCT00898807 (follow link to view full record on ct.gov in new window)
Official Title: 
A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease
Study Start Date: 
July 2009
Study End Date: 
September 2013
Disease Stage: 
Early
Middle
Enrollment: 
200