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ABT-126 · 3 trials · 2 indications
vital signs, electrocardiogram (ECG), neurological examination, laboratory tests, number of subjects with adverse events, Columbia-Suicide Severity Rating Scale (C-SSRS)
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | ABT-126 Low Dose |
| 2 | EXPERIMENTAL | ABT-126 High Dose |
| 3 | EXPERIMENTAL | Placebo for ABT-126 |
| 20mg of ABT-126 QD | ACTIVE_COMPARATOR | 20 mg of ABT-126 QD for 10 days |
| 30mg and 45mg ABT-126 QD | ACTIVE_COMPARATOR | 30 mg and 45mg of ABT-126 QD for 21 days |
| Name | Type | Description |
|---|---|---|
| ABT-126 | DRUG | Dose 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. |
| Placebo | DRUG | Placebo 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-126 | DRUG | Matching Placebo for Arms 1 \& 2 |
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....
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ABT-126 is an investigational small molecule developed by Abbott Laboratories for neurological conditions. It has been studied in Alzheimer's disease and schizophrenia. It is a Phase 1 clinical candidate and has not been approved by the FDA. All three of its listed Phase 1 trials are completed, with no active trials currently listed.
ABT-126 has been studied in Alzheimer's disease as an investigational treatment. Two completed Phase 1 trials enrolled participants with Alzheimer's disease: NCT01482845, which assessed safety, tolerability and pharmacokinetics in 20 subjects, and NCT00867399, a safety and tolerability study in 30 elderly participants. It is not an approved therapy for Alzheimer's disease.
ABT-126 targets CHRNA7, the alpha-7 nicotinic acetylcholine receptor, and acts as an agonist at this target. CHRNA7 is a ligand-gated ion channel involved in cholinergic signaling in the nervous system. This receptor target is of interest in neurological and psychiatric conditions, including Alzheimer's disease and schizophrenia.
ABT-126 is developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. Abbott is the sponsor of the clinical program studying ABT-126 in Alzheimer's disease and schizophrenia. The compound is an investigational small molecule and is not currently an approved product.
ABT-126 is in Phase 1 clinical development. Three Phase 1 trials are listed, all completed, with no active trials reported. The studies enrolled a total of 66 participants across Alzheimer's disease and schizophrenia indications. ABT-126 is investigational and has not been approved by the FDA for any indication.
Three completed Phase 1 trials of ABT-126 are registered: NCT01482845 in Alzheimer's disease, NCT01043458 in stable schizophrenia, and NCT00867399 in elderly participants. All were conducted in the United States. The trials were randomized, double-blind and controlled, with total enrollment of 66 participants across the program.