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ABT-126

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Abbott Laboratories|Trials Updated: May 2, 2012

Development status

Highest phase Phase 2 run by AbbVie (prior sponsor, Abbott) (NCT01655680)
Phase scored for ABTPhase 1
Registered trials 14 across 3 sponsors since Mar 2009

Target and mechanism

Molecular targetCHRNA7
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials5
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

ABT-126 · 5 trials · 4 indications

Phase 1 5
NCT01482845A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's DiseaseAlzheimer's Disease
COMPLETED20 Analytics
NCT01043458Pharmacokinetic Study of ABT-126 in Stable Subjects With SchizophreniaSchizophrenia
COMPLETED16 Analytics
NCT00959634Pharmacokinetic Study of ABT-126 in Healthy VolunteersHealthy Volunteers
COMPLETED20 Analytics
NCT00912431Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy VolunteersHealthy
COMPLETED10 Analytics
NCT00867399A Safety and Tolerability Study of ABT-126 in ElderlyAlzheimer's Disease
COMPLETED30 Analytics
PHASE1COMPLETED
A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetic Study of ABT-126 in Stable Subjects With Schizophrenia
SchizophreniaUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetic Study of ABT-126 in Healthy Volunteers
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers
HealthyUnlock trial analytics
PHASE1COMPLETED
A Safety and Tolerability Study of ABT-126 in Elderly
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability assessments
From Day 1 through Day 17

vital signs, electrocardiogram (ECG), neurological examination, laboratory tests, number of subjects with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS)

Adverse Events
Duration of study
ABT-126 levels in blood (plasma)
Pre-dose to 144 hours post-dose
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
Pre-dose to 72 hours post-dose
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)
One day before dosing through day of last dose and up to 6 days after last dose
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical examination and neurological examination)
Day 1 thru Day 4 in Periods 1 and 2
Pharmacokinetic samples
Day 1 (up to 24-hour post dose) in Periods 1 and 2
Cerebrospinal Fluid samples
Day 1 (up to 24-hour post dose) in Periods 1 and 2
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Study Days -1 thru Day 28
Assess the Pharmacokinetics
Study Days -1 thru Day 28

Secondary Endpoints

Pharmacokinetic evaluation profile
Blood collection prior to, and at 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24, 72, 120, and 168 hours after dosing on Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
1EXPERIMENTALABT-126 Low Dose
2EXPERIMENTALABT-126 High Dose
3EXPERIMENTALPlacebo for ABT-126
20mg of ABT-126 QDACTIVE_COMPARATOR20 mg of ABT-126 QD for 10 days
30mg and 45mg ABT-126 QDACTIVE_COMPARATOR30 mg and 45mg of ABT-126 QD for 21 days

Interventions

NameTypeDescription
ABT-126DRUGDose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.
PlaceboDRUGPlacebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.
Placebo for ABT-126DRUGMatching Placebo for Arms 1 \& 2
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Eligibility Criteria

Age Range55 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria 1. Male or female and age between 55 and 90 years, inclusive. 2. The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease (AD). 3....

Countries:United States
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Frequently asked questions about ABT-126

What is ABT-126?

ABT-126 is an investigational small molecule developed by Abbott Laboratories for neurological conditions. It has been studied in Phase 1 clinical trials in Alzheimer's disease, schizophrenia, and healthy volunteers. It is not approved and remains in early clinical development.

What does ABT-126 target?

ABT-126 targets CHRNA7, the alpha-7 nicotinic acetylcholine receptor, and acts as an agonist at this target. This receptor is associated with cholinergic signaling relevant to neurological and cognitive function, which is why ABT-126 has been evaluated in Alzheimer's disease and schizophrenia.

Who makes ABT-126?

ABT-126 is developed by Abbott Laboratories, which trades under the ticker ABT. Abbott sponsored the Phase 1 clinical studies of the compound in Alzheimer's disease, schizophrenia, and healthy volunteers.

What phase is ABT-126 in?

ABT-126 is in Phase 1 clinical development. All of its recorded trials are Phase 1 studies, and none are currently active. It is an investigational agent and has not been approved for any indication.

What clinical trials is ABT-126 in?

ABT-126 has been studied in completed Phase 1 trials including NCT01482845 in Alzheimer's disease, NCT01043458 in schizophrenia, NCT00959634 in healthy volunteers, and NCT00912431, a pharmacokinetic and exploratory biomarker study in healthy volunteers. These studies enrolled a total of 50 participants across randomized, double-blind, controlled designs.

What is ABT-126 used for in Alzheimer's disease?

ABT-126 has been evaluated in a Phase 1 study in subjects with Alzheimer's disease, NCT01482845, which assessed safety, tolerability, and pharmacokinetics in 20 participants aged 55 and older in the United States. It is investigational and not an approved treatment for Alzheimer's disease.