Start:
July 2009
End:
September 2013
Enrollment:
200
The purpose of this study is to evaluate the safety and efficacy of the drug citalopram for treating agitation in Alzheimer's dementia.
Minimum Age: N/A
Maximum Age: N/A
++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
++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
Contact study personnel listed either under the general study contact or the location nearest you.
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Lead: Johns Hopkins University
Collaborator Sponsor
Source: ClinicalTrials.gov ID: NCT00898807
An official website of the U.S. government, managed by the National Institute on Aging at the National Institutes of Health