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Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia.

Publication ,  Journal Article
Javitt, DC; Buchanan, RW; Keefe, RSE; Kern, R; McMahon, RP; Green, MF; Lieberman, J; Goff, DC; Csernansky, JG; McEvoy, JP; Jarskog, F ...
Published in: Schizophr Res
April 2012

BACKGROUND: Cognitive dysfunction is a key predictor of functional disability in schizophrenia. Davunetide (AL-108, NAP) is an intranasally administered peptide currently being developed for treatment of Alzheimer's disease and related disorders. This study investigates effects of davunetide on cognition in schizophrenia. METHOD: Sixty-three subjects with schizophrenia received davunetide at one of two different doses (5, 30 mg) or placebo for 12 weeks in a multicenter, double-blind, parallel-group randomized clinical trial. The MATRICS Consensus Cognitive Battery (MCCB) assessed cognitive effects. The UCSD Performance-based Skills Assessment (UPSA) and the Schizophrenia Cognition Rating Scale (SCoRS) assessed functional capacity. Subjects continued their current antipsychotic treatment during the trial. RESULTS: There were no significant differences in MCCB change between davunetide and placebo over the three treatment arms (p=.45). Estimated effect-size (d) values were .34 and .21 favoring the 5 and 30 mg doses vs. placebo, respectively. For UPSA, there was a significant main effect of treatment across study arms (p=.048). Between-group effect size (d) values were.74 and .48, favoring the 5 and 30 mg doses, respectively. No significant effects were observed on the SCoRS or on symptom ratings. No significant side effects or adverse events were observed. CONCLUSION: Davunetide was well tolerated. Effects of davunetide on MCCB-rated cognition were not significant relative to placebo. In contrast, a significant beneficial effect was detected for the UPSA. Based upon effect-size considerations, sample sizes of at least 45-50 subjects/group would be required to obtain significant effects on both MCCB and UPSA, providing guidance for continued clinical development in schizophrenia.

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Published In

Schizophr Res

DOI

EISSN

1573-2509

Publication Date

April 2012

Volume

136

Issue

1-3

Start / End Page

25 / 31

Location

Netherlands

Related Subject Headings

  • Verbal Learning
  • Schizophrenic Psychology
  • Schizophrenia
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Problem Solving
  • Oligopeptides
  • Neuropsychological Tests
  • Neuroprotective Agents
  • Middle Aged
 

Citation

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Javitt, D. C., Buchanan, R. W., Keefe, R. S. E., Kern, R., McMahon, R. P., Green, M. F., … Marder, S. R. (2012). Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia. Schizophr Res, 136(1–3), 25–31. https://doi.org/10.1016/j.schres.2011.11.001
Javitt, Daniel C., Robert W. Buchanan, Richard S. E. Keefe, Robert Kern, Robert P. McMahon, Michael F. Green, Jeffrey Lieberman, et al. “Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia.Schizophr Res 136, no. 1–3 (April 2012): 25–31. https://doi.org/10.1016/j.schres.2011.11.001.
Javitt DC, Buchanan RW, Keefe RSE, Kern R, McMahon RP, Green MF, et al. Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia. Schizophr Res. 2012 Apr;136(1–3):25–31.
Javitt, Daniel C., et al. “Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia.Schizophr Res, vol. 136, no. 1–3, Apr. 2012, pp. 25–31. Pubmed, doi:10.1016/j.schres.2011.11.001.
Javitt DC, Buchanan RW, Keefe RSE, Kern R, McMahon RP, Green MF, Lieberman J, Goff DC, Csernansky JG, McEvoy JP, Jarskog F, Seidman LJ, Gold JM, Kimhy D, Nolan KS, Barch DS, Ball MP, Robinson J, Marder SR. Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia. Schizophr Res. 2012 Apr;136(1–3):25–31.
Journal cover image

Published In

Schizophr Res

DOI

EISSN

1573-2509

Publication Date

April 2012

Volume

136

Issue

1-3

Start / End Page

25 / 31

Location

Netherlands

Related Subject Headings

  • Verbal Learning
  • Schizophrenic Psychology
  • Schizophrenia
  • Psychiatry
  • Psychiatric Status Rating Scales
  • Problem Solving
  • Oligopeptides
  • Neuropsychological Tests
  • Neuroprotective Agents
  • Middle Aged