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ABT-126

Phase 2

Alzheimer's Disease | Small molecule | Neurology |AbbVie Inc.|Trials Updated: Jul 7, 2021

ABT-126 development status

Highest phase Phase 2
Registered trials 14 across 3 sponsors since Mar 2009

ABT-126 target and mechanism

Molecular targetCHRNA7
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials5
Total Enrollment1,504

FDA Designations

No designations recorded

ABT-126 clinical trials

ABT-126 · 5 trials · 3 indications

Phase 2 5
NCT01678755A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in SchizophreniaSchizophrenia
COMPLETED157 Analytics
NCT01655680A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in SchizophreniaSchizophrenia
COMPLETED432 Analytics
NCT01549834Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase InhibitorsAlzheimer's Disease
COMPLETED434 Analytics
NCT01095562Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With SchizophreniaCognitive Deficits in Schizophrenia
COMPLETED207 Analytics
NCT00948909Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED274 Analytics
PHASE2COMPLETED
A Phase 2 Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
A Study to Evaluate ABT-126 for the Treatment of Cognitive Deficits in Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Alzheimer's DiseaseUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study for Cognitive Deficits in Adult Subjects With Schizophrenia
Cognitive Deficits in SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Cognition: MCCB (MATRICS Consensus Cognitive Battery) change from baseline to week 12
Change from baseline to week 12

Rater based interview

Cognition: MCCB (MATRICS Consensus Cognitive Battery)
Change from baseline to week 24

Rater based interview

Alzheimer's Disease Assessment Scale - cognitive subscale
Measurements up through 24 weeks

An assessment tool which focuses on cognitive function and memory

Cognition: MCCB
Measurements from screening period through 12-week treatment period
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Measurements up through 12 weeks.

Secondary Endpoints

Functioning: UPSA-2 (University of California San Diego Performance-based Skills Assessment-2)
Measurements from screening period up through week 12
Symptom Severity: PANSS (Positive and Negative Syndrome Scale)
Measurements from screening period up through week 12
Symptom Severity: NSA-16 (16-item version of the Negative Symptom Assessment Scale)
Measurements from screening period up through week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-126 Low DoseEXPERIMENTALABT-126 Low Dose
ABT-126 High DoseEXPERIMENTALABT-126 High Dose
PlaceboPLACEBO_COMPARATORPlacebo
ABT-126 Middle DoseEXPERIMENTALABT-126 Middle Dose
sugar pillPLACEBO_COMPARATORPlacebo
ABT-126 Dose 1EXPERIMENTAL -
ABT-126 Dose 2EXPERIMENTAL -
A. Sugar PillPLACEBO_COMPARATOR -
B. ABT-126EXPERIMENTAL -
C. ABT-126EXPERIMENTAL -
D. donepezilACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ABT-126DRUGABT-126 Low Dose
PlaceboDRUGPlacebo
donepezilDRUGActive comparator intervention
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Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Has a current Diagnostic and Statistical Manual of Mental Disorders-, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of schizophrenia confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). * Is clinically stable while receiving a regimen of one or two all...

Countries:United StatesRussiaUnited KingdomCanadaFranceGermanyGreeceSouth AfricaBulgariaCzechiaSlovakia
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Frequently asked questions about ABT-126

What is ABT-126?

ABT-126 is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) for neurological conditions. It has been studied in Phase 2 clinical trials for Alzheimer's disease and for cognitive deficits in schizophrenia. It is not an approved therapy and remains in clinical development.

What does ABT-126 target?

ABT-126 targets CHRNA7, the alpha-7 nicotinic acetylcholine receptor. It acts as an agonist at this receptor. CHRNA7 is a ligand-gated ion channel involved in cholinergic signaling, and agonism of this target has been explored as an approach in cognitive impairment associated with neurological and psychiatric conditions.

What is ABT-126 used for?

ABT-126 has been studied for Alzheimer's disease and for cognitive deficits in schizophrenia. Its Phase 2 program included a trial in mild to moderate Alzheimer's disease patients on stable doses of acetylcholinesterase inhibitors, and trials in adults with schizophrenia or cognitive deficits in schizophrenia. It is investigational and not approved for any use.

Who makes ABT-126?

ABT-126 is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie sponsored the Phase 2 clinical program evaluating the compound in Alzheimer's disease and in cognitive deficits in schizophrenia.

What phase is ABT-126 in?

ABT-126 is in Phase 2 development. All of its recorded trials are Phase 2 studies, and all are completed, with no active trials ongoing. The program covered Alzheimer's disease and cognitive deficits in schizophrenia. ABT-126 is investigational and has not been approved by the FDA.

What clinical trials is ABT-126 in?

ABT-126 was evaluated in completed Phase 2 trials including NCT01678755 and NCT01655680 in cognitive deficits in schizophrenia, NCT01549834 in mild to moderate Alzheimer's disease, and NCT01095562 in cognitive deficits in adult subjects with schizophrenia. These randomized, double-blind, placebo-controlled studies enrolled participants across the United States, Russia, the United Kingdom, Canada, France, Germany, Greece, and South Africa.