Citalopram for Agitation in Alzheimer's Disease

Inclusion criteria

   - Probable Alzheimer's disease (National Institute of Neurological and Communicative
   Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association
   criteria), with Mini-Mental score of 5-28 inclusive

   - A medication for agitation is appropriate, in the opinion of the study physician

   - Clinically significant agitation for which either

      1. the frequency of agitation as assessed by the Neuropsychiatric Inventory (NPI) is
      'Very frequently', or

      2. the frequency of agitation as assessed by the NPI is 'Frequently' AND the
      severity of the agitation as assessed by the NPI is 'Moderate', or 'Marked'

   - Provision of informed consent for participation in the study by patient or surrogate
   (if necessary) and caregiver

   - 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

   - No change to Alzheimer's disease (AD) medications within the month preceding
   randomization, including starting, stopping, or dosage modifications

Exclusion criteria

   - Meets criteria for Major Depressive Episode by Diagnostic and Statistical Manual of
   Mental Disorders, 4th edition, text revision (DSM-IV (TR)) criteria

   - Presence of a 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 in the
   opinion of the study physician

   - Prolonged measure of the time between the start of the Q wave and the end of the T
   wave in the heart's electrical cycle (QT interval)

   - Treatment with citalopram is contraindicated in the opinion of the study physician

   - Failure of past treatment with citalopram for agitation after adequate trial at a
   minimally accepted dose (greater than or equal to 20 mg/day)

   - Treatment with a medication that would prohibit the safe concurrent use of citalopram,
   such as Monoamine oxidases (MAO) inhibitors

   - Need for psychiatric hospitalization or 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 than dilantin), 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, in the opinion of the study physician, makes it medically
   inappropriate or risky for the patient to enroll in the trial