NCT01730768

Brief Summary

This is a study in chronic stable Schizophrenia with the purpose to answer the question of whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well defined chronic stable patient population treated with antipsychotics as standard of care, and thus to support the future development of AQW051 for the treatment of cognitive impairment associated with Schizophrenia (CIAS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 24, 2020

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 6, 2012

Last Update Submit

December 16, 2020

Conditions

Schizophrenia

Keywords

schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState

Outcome Measures

Primary Outcomes (1)

  • Visual learning and memory at 4 weeks

    The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.

    4 weeks

Secondary Outcomes (3)

  • Effect on cognitive function after 12 weeks of treatment - CogState test battery.

    Baseline, 12 weeks

  • Effect on cognitive function after 12 weeks of treatment - MCCB

    Baseline, 12 weeks

  • Number of patients with adverse events

    12 weeks

Study Arms (2)

AQW051 10 mg/day

EXPERIMENTAL

Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84.

Drug: AQW051

Placebo to AQW051

PLACEBO COMPARATOR

Matching placebo administered orally.

Drug: Placebo

Interventions

AQW051DRUG
AQW051 10 mg/day
PlaceboDRUG
Placebo to AQW051

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia
  • Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole.
  • Specific cognitive impairment
  • Smokers and non-smokers

You may not qualify if:

  • Current treatment with an anticholinergic or other agent known to adversely interfere with the cholinergic system, and/ or treatment with cholinesterase inhibitor within the last three (3) months prior to dosing.
  • Current treatment with conventional antipsychotics (e.g fluphenazine, haloperidol) or clozapine.
  • History of neuroleptic malignant syndrome.
  • Diagnosis of substance abuse (other than nicotine) within the last month and alcohol or substance dependence (other than nicotine) within the last 6 months.
  • Score 4 or 5 on the Suicidal Ideation item or any "yes" on the Suicidal Behavior item of the CSSR-S that is related to suicidal behavior occurring during the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Novartis Investigative Site

Garden Grove, California, 92845, United States

Location

Novartis Investigative Site

Glendale, California, 91206, United States

Location

Novartis Investigative Site

National City, California, 91950, United States

Location

Novartis Investigative Site

Oakland, California, 94612, United States

Location

Novartis Investigative Site

Pico Rivera, California, 90660, United States

Location

Novartis Investigative Site

San Diego, California, 92102, United States

Location

Novartis Investigative Site

Miramar, Florida, 33025, United States

Location

Novartis Investigative Site

Atlanta, Georgia, 30308, United States

Location

Novartis Investigative Site

Marlton, New Jersey, 08053, United States

Location

Novartis Investigative Site

Staten Island, New York, 10305, United States

Location

Novartis Investigative Site

Staten Island, New York, 10312, United States

Location

Novartis Investigative Site

Philadelphia, Pennsylvania, 19131, United States

Location

Novartis Investigative Site

Irving, Texas, 75062, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaSpatial Learning

Interventions

3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSpatial BehaviorBehavior

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2012

First Posted

November 21, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 24, 2020

Record last verified: 2017-03

Locations

US(13)