Start: July 2009
End: September 2013
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.
Lead: Johns Hopkins University
Source: ClinicalTrials.gov ID: NCT00898807