March 18, 2016
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ABT-126 improves cognition in schizophrenia, but only for nonsmokers

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ABT-126, a selective 7 nicotinic receptor partial agonist, significantly improved cognitive outcomes in individuals with schizophrenia who were nonsmokers, according to recent findings.

“Although current therapies significantly improve the positive symptoms of schizophrenia, they do not noticeably improve cognition, and there are currently no approved pharmacological treatments for this indication. Nonpharmacological treatments have demonstrated some benefit, but they are not widely used and require considerable time and effort,” George M. Haig, PharmD, of AbbVie Inc., Chicago, and colleagues wrote.

To evaluate efficacy and safety of ABT-126 for schizophrenia, researchers conducted a 12-week, double-blind, placebo-controlled, parallel-group phase 2 study in 22 center in the United States. Clinically stable individuals with schizophrenia (n = 207) were assigned to receive 10 mg or 25 mg of ABT-126 or placebo once daily. Researchers assessed change in MATRICS Consensus Cognitive Battery (MCCB) composite score, MCCB domain scores and UCSD Performance-Based Skills Assessment total score.

ABT-126 was associated with an insignificant improvement in MCCB composite scores at week 12, with least square mean differences of 1.3 for those who received 10 mg and 1.5 for those who received 25 mg, compared with placebo.

There was a significant treatment-by-smoking status interaction regarding mean change in MCCB composite score. Compared with placebo, there was a mean difference of 2.9 in nonsmokers who received 10 mg, and 5.2 in nonsmokers who received 25 mg. There was no difference observed among smokers.

Nonsmokers in the 25 mg group exhibited significant improvements in verbal learning, working memory and attention/vigilance, compared with placebo.

Dizziness, diarrhea and fatigue were the most frequently reported adverse events for ABT-126.

“ABT-126 demonstrated a procognitive effect in stable, nonsmoking subjects with schizophrenia, as demonstrated by improvements on the MCCB. These data support further evaluation of ABT-126 in both smokers and nonsmokers. ABT-126 was generally safe and well tolerated in this population,” the researchers concluded. – by Amanda Oldt

Disclosure: Haig, is an employee of AbbVie and holds AbbVie stock and/or stock options and is an AbbVie patent holder. Please see the full study for a list of all authors’ relevant financial disclosures.