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ABT-126

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment50

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 used for?

ABT-126 is an investigational small molecule being studied in neurology for Alzheimer's disease, schizophrenia, and in healthy volunteers. It has been evaluated in Phase 1 clinical trials for safety, tolerability, and pharmacokinetics. ABT-126 is not approved and remains in clinical development.

Who makes ABT-126?

ABT-126 is being developed by Abbott Laboratories, traded under the ticker ABT. The company has sponsored Phase 1 clinical trials of the drug in the United States.

What phase is ABT-126 in?

ABT-126 is in Phase 1 clinical development. All completed trials for the drug are Phase 1 studies, and it is not FDA approved. The drug remains investigational.

What clinical trials is ABT-126 in?

ABT-126 has completed four Phase 1 trials: NCT00867399 in elderly with Alzheimer's disease, NCT00912431 in healthy volunteers, NCT01043458 in schizophrenia, and NCT01482845 in Alzheimer's disease. All were conducted in the United States.

Is ABT-126 the same as any other drug?

No alternative names for ABT-126 have been disclosed. The drug is referred to solely as ABT-126 in clinical trial records.

What is the development status of ABT-126?

ABT-126 is an investigational drug that has completed Phase 1 trials. It is not approved for any use. The trials were randomized, double-blind, and controlled, but no later-phase studies are listed.