Citalopram for Agitation in Alzheimer's Disease (CitAD)
Citalopram for Agitation in Alzheimer's Disease (CitAD)
Overall Status:
No longer recruiting
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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Primary Contact |
|---|---|---|---|---|
Geolocation is 34.0220127, -118.2892046 | Los Angeles | California | 90089 | Name: Phone: |
Geolocation is 37.3813444, -122.1802812 | Palo Alto | California | 94304 | Name: Phone: |
Geolocation is 39.2713976, -76.5603828 | Baltimore | Maryland | 21224 | Name: Phone: |
Geolocation is 40.8409822, -73.9447994 | New York | New York | 10032 | Name: Phone: |
Geolocation is 43.1961891, -77.8138553 | Rochester | New York | 14559 | Name: Phone: |
Geolocation is 39.9583587, -75.1953934 | Philadelphia | Pennsylvania | 19104 | Name: Phone: |
Geolocation is 32.9221152, -80.0367259 | Charleston | South Carolina | 29406 | Name: Phone: |
Geolocation is 43.6435768, -79.4176391 | 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:
| Name | Role | Affiliation |
|---|---|---|
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:
| Name | Phone |
|---|---|
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
Trial References:
