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Cognitive Test Battery 1, Cognitive Test Battery 2

Phase 1

Schizophrenia | Unknown | Psychiatry |Johnson & Johnson|Last Updated: Jun 17, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
ACTIVE_CONTROLLED
Total Trials1
Total Enrollment51
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01788436A Study to Assess Learning Performance in Patients With Schizophrenia and Young and Elderly Healthy VolunteersEARLY_PHASE1 COMPLETED 51Nov 1, 2012May 1, 2014Jun 17, 20141 Belgium
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Study Endpoints
Primary Endpoints
Measurement of implicit and explicit learning through cognitive testing over a period of 7 days
7 days

The cognitive data will be summarized and summary statistics calculated (including mean, standard deviation, median, minimum, and maximum values) for each experiment and participants group.

Secondary Endpoints
Incidence of Adverse Events
7 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Group 1: Patients with schizophreniaEXPERIMENTAL -
Group 2: Young healthy volunteersACTIVE_COMPARATOR -
Group 3: Elderly healthy volunteersEXPERIMENTAL -
Interventions
NameTypeDescription
Cognitive Test Battery 1BEHAVIORALThe Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT\_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT\_Expl); Delayed Recall and Recognition Test; and Pursuit rotor.
Cognitive Test Battery 2BEHAVIORALThe Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task.
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Group 1 (patients with schizophrenia): * Be a man or woman between 18 and 55 years of age, inclusive * Has a known history of schizophrenia of at least 12 months by the referring psychiatrist * Receives stable antipsychotic drug therapy (maximally 2) for at least 6 weeks prior...

Countries:Belgium
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