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AQW051 · 4 trials · 4 indications
The primary objective is to evaluate the pro-cognitive effects of AQW051 in a chronic stable schizophrenic patient population at week 4 as measured by the absolute change from baseline in CPAL number of errors (CogState battery) at week 4.
Dyskinesia with a maximal score of 24.
Anti-parkinsonian effect in PD patients.
Safety and tolerability of AQW051 as measured by the number of participants with adverse events, any clinically significant abnormalities in safety labs or electrocardiograms (ECGs), and relevant orthostatic changes in blood pressure
| Arm | Type | Description |
|---|---|---|
| AQW051 10 mg/day | EXPERIMENTAL | Two 5mg AQW051 capsules will be taken orally daily by patients from Day 1 until Day 84. |
| Placebo to AQW051 | PLACEBO_COMPARATOR | Matching placebo administered orally. |
| AQW051 High Dose | EXPERIMENTAL | AQW051 high dose daily given orally for 28 days. |
| AQW051 Low Dose | EXPERIMENTAL | AQW051 low dose daily given orally for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Placebo daily given orally for 28 days. |
| AQW051 Dose 1 | EXPERIMENTAL | - |
| AQW051 Dose 2 | EXPERIMENTAL | - |
| AQW051 Dose 3 | EXPERIMENTAL | - |
| AQW051 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AQW051 | DRUG | - |
| Placebo | DRUG | - |
| Placebo (single and multiple doses) | DRUG | - |
| AQW051 2 mg (single and multiple doses) | DRUG | - |
| AQW051 15mg (single and multiple doses) | DRUG | - |
| AQW051 100mg (single dose), and 50mg (multiple doses) | DRUG | - |
Inclusion Criteria: * Diagnosis of schizophrenia * Symptomatically stable and currently treated with a stable regimen for at least 3 (three) months prior to dosing with one of the following second generation of antipsychotics: risperidone, paliperidone, quetiapine, ziprasidone, aripiprazole. * Spec...
AQW051 is an investigational small molecule developed by Novartis AG for neurological and psychiatric conditions. It has been studied in schizophrenia and in L-dopa induced dyskinesias in patients with Parkinson's disease. It is a partial agonist of CHRNA7, also known as the alpha-7 nicotinic acetylcholine receptor.
AQW051 has been studied as a treatment for cognitive impairment in stable schizophrenia, with trials evaluating its effects on cognition in patients with chronic stable schizophrenia. It is investigational and has not been approved for any indication. The completed Phase 2 trials enrolled adults aged 18 years and older.
AQW051 targets CHRNA7, the alpha-7 nicotinic acetylcholine receptor, and acts as a partial agonist at this target. This receptor is associated with cognitive function, which is why the compound was studied for cognitive effects in schizophrenia and for L-dopa induced dyskinesias in Parkinson's disease.
AQW051 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the clinical trials of AQW051 in schizophrenia and in L-dopa induced dyskinesias in patients with Parkinson's disease.
AQW051 is in Phase 2 development. It is investigational and has not been approved for any indication. The Phase 2 trials in schizophrenia and in L-dopa induced dyskinesias have been completed, and no trials are currently active.
AQW051 has been evaluated in completed trials including NCT01730768, a Phase 2 study of once daily doses on cognition in stable schizophrenia patients, and NCT01474421, a Phase 2 study in L-dopa induced dyskinesias in Parkinson's disease. Other completed studies include NCT01163227 and the Phase 1 trial NCT00825539.