A Multicenter Study of NAP (AL-108) in Schizophrenia
Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
Participant gender:
Summary
The TURNS is a NIMH-funded contract for the evaluation of new compounds for the treatment of
cognitive impairments in schizophrenia (HHSN 27820044 1003C; P.I.: Steve Marder, M.D.).
Despite advances in the safety, tolerability, and effectiveness of antipsychotic medications
for the treatment of schizophrenia, many patients continue to be plagued by impairments in
social and work functioning. Persons with schizophrenia commonly show deficits in a number of
areas of cognition that include impairments in attention, memory, and executive functioning
(the ability and organize one's behavior). Importantly, a large body of literature now shows
a link between cognition and community functioning in schizophrenia. It is believed that
treatments that improve cognitive deficits may lead to improvements in work and social
functioning.
One approach to improve the community functioning of patients with schizophrenia is to
develop new agents that treat the cognitive deficits of the illness. A promising agent is
called AL-108. This drug is administered as a nasal spray. Studies in animals suggest that
this drug may protect neurons and may improve cognition in schizophrenia. The current study
is a twelve-week multicenter, double-blind, randomized clinical trial of two doses of AL-108
(5 and 30 mg/day intranasally) versus placebo in the treatment of persistent cognitive
dysfunction in schizophrenia. The study medication will be added to patients' current
atypical antipsychotic medication or to their current injectable first-generation
antipsychotic medication. The primary outcome measure will consist of the composite score of
the MATRICS neuropsychological battery. Secondary outcome measures will include scores on
symptoms, functional outcome, and safety measures. Sixty clinically stable patients with
schizophrenia, drawn from eight sites, will participate in the study. Twenty-five patients
will be enrolled at UCLA.
Phase:
Phase 2
Details
Lead Sponsor:
University of California, Los Angeles
Collaborators:
Beth Israel Deaconess Medical Center Columbia University Duke University Massachusetts General Hospital Nathan Kline Institute for Psychiatric Research University of Maryland University of Maryland, College Park Washington University School of Medicine