Treatment of Psychosis and Agitation in Alzheimer's Disease
Status:
Completed
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
Clinically, many patients with AD show no response or minimal response to antipsychotics for
symptoms of agitation/aggression or psychosis, or they have intolerable side effects on these
medications. Antipsychotics have a wide range of side effects, including the risk of
increased mortality (60-70% higher rate of death on antipsychotic compared to placebo) that
led to an FDA black box warning for patients with dementia; a more recent review and
meta-analysis showed a 54% increased risk of mortality. In addition, some patients show only
partial response to antipsychotics and symptoms persist. For these reasons, the investigators
need to study alternative treatment strategies. Currently, there is no FDA-approved
medication for the treatment of psychosis or agitation in AD.
The investigators innovative project will examine the efficacy and side effects of low dose
lithium treatment of agitation/aggression with or without psychosis in 80 patients with AD in
a randomized, doubleblind, placebo-controlled, 12-week trial (essentially a Phase II trial).
The results will determine the potential for a large-scale clinical trial (Phase III) to
establish the utility of lithium in these patients.