NCT01163227

Brief Summary

This PoC study is designed to assess the cognitive effects of doses of AQW051 in patients with chronic stable schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

December 24, 2020

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

July 12, 2010

Last Update Submit

December 16, 2020

Conditions

Schizophrenia Disorders

Keywords

Hallucinations,psychotic,delusions,cognitive deficits

Outcome Measures

Primary Outcomes (1)

  • Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests

    132 days Part A, 121 days Part B (screening to study completion)

Secondary Outcomes (4)

  • Effects of single oral doses of AQW051 versus placebo on cognitive function as measured by selected MATRICS Consensus Cognitive Battery (MCCB) tests

    132 days Part A, 121 days Part B (screening to study completion)

  • Effects of multiple oral doses of AQW051 versus placebo on cognitive function as measured by selected CogState tests and selected MCCB tests

    132 days Part A, 121 days Part B (screening to study completion)

  • Correlation of the cognitive domains measured by MCCB versus CogState

    132 days Part A, 121 days Part B (screening to study completion)

  • Pharmacokinetics, safety and tolerability of single and multiple doses of AQW051 as compared to placebo

    132 days Part A, 121 days Part B (screening to study completion)

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: Placebo (single and multiple doses)

AQW051 Dose 1

EXPERIMENTAL
Drug: AQW051 2 mg (single and multiple doses)

AQW051 Dose 2

EXPERIMENTAL
Drug: AQW051 15mg (single and multiple doses)

AQW051 Dose 3

EXPERIMENTAL
Drug: AQW051 100mg (single dose), and 50mg (multiple doses)

Interventions

Placebo (single and multiple doses)DRUG
Placebo
AQW051 2 mg (single and multiple doses)DRUG
AQW051 Dose 1
AQW051 15mg (single and multiple doses)DRUG
AQW051 Dose 2
AQW051 100mg (single dose), and 50mg (multiple doses)DRUG
AQW051 Dose 3

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PAREXEL (California Clinical Trials Medical Group), 1560 Chevy Chase Drive, Suite 140,

Glendale, California, 91206, United States

Location

CRI Worldwide, 1113 Hospital Dr. Suite 202,

Willingboro, New Jersey, 08046, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaHallucinationsMental DisordersDelusionsCognition Disorders

Interventions

Single Person3-(6-p-tolylpyridin-3-yloxy)-1-azabicyclo(2.2.2)octane

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Marital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 15, 2010

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

December 24, 2020

Record last verified: 2013-03

Locations

US(2)