A Multicenter Study of NAP (AL-108) in Schizophrenia

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.

Conditions

• Schizophrenia

Interventions

DRUG

AL-108

AL-108, 5 mg/day- one spray in each nostril once per day

DRUG

AL-108

AL-108, 30 mg/day- 3 sprays in each nostril, twice per day

DRUG

Placebo

Placebo- 3 sprays in each nostril, twice per day

DRUG

Placebo

Placebo- one spray in each nostril, once per day

Sponsors & Collaborators

• University of Maryland

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Massachusetts General Hospital

  collaborator OTHER

• Nathan Kline Institute for Psychiatric Research

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Duke University

  collaborator OTHER

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Daniel C Javitt, MD, PhD · Nathan Kline Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-07-31

Primary Completion

2009-04-30

Completion

2009-04-30

Countries

• United States

Study Locations