Abstract
This progress report briefly describes the rationale and study design for the first cross-national clinical study of a positive AMPA-type glutamate receptor modulator in subjects with mild cognitive impairment (MCI). The study medication for the double-blind, placebo-controlled trial, the Ampakine® CX516, represents a novel pharmacological approach to the treatment of memory disorders. Previous preclinical and pilot clinical studies have shown that CX516 has the ability to enhance memory and cognition. Design of the trial, including outcome measures and inclusion criteria, was aided by an international panel of experts in the newly emerging field of MCI.
Similar content being viewed by others
References
Goff D. C., Leahy L., Berman I., Posever T., Herz L., Leon A. C., Johnson S. A., and Lynch G. (2001) A placebo-controlled pilot study of the Ampakine CX516 added to clozapine in schizophrenia. J. Clin. Psychopharm. 21, 484–487.
Hampson R. E., Rogers G., Lynch G., and Deadwyler S. A. (1998) Facilitative effects of the Ampakine CX516 on short-term memory in rats: enhancement of delayed-nonmatch-to sample performance. J. Neurosci. 18, 2740–2747.
Ingvar M., Ambros-Ingerson J., Davis M., Granger R., Kessler M., Rogers G. A., et al. (1997) Enhancement by an Ampakine of memory encoding in humans. Exp. Neurol. 146, 553–559.
Lynch G., Kessler M., Rogers G., Ambros-Ingerson J., Granger R., and Schehr R. S. (1996) Psychological effects of a drug that facilitates brain AMPA receptors. Int. Clin. Psychopharm. 11, 13–19.
Lynch G., Granger R., Ambros-Ingerson J., Davis C. M., Kessler M., and Schehr R. (1997) Evidence that a positive modulator of AMPA-type glutamate receptors improves delayed recall in aged humans. Exp. Neurol. 145, 89–92.
Mohs R. C., Knopman D., Petersen R. C., Ferris S. H., Ernesto C., Grundman M., et al. (1997) Development of cognitive instruments for use in clinical trials of antidementia drugs: additions to the Alzheimer’s Disease Assessment Scale that broaden its scope. Alzheimer’s Dis. Assoc. Disord. 11, S13-S21.
Morris J. C., (1993) The clinical dementia rating(CDR): current version and scoring rules. Neurology 43, 2412–2414.
Peterson R. C., Smith G. E., Waring S. C., Ivnik R. J., Tangalos E. G., and Kokmen E. (1999) Mild Cognitive Impairment. Clinical characterization and outcome. Arch. Neurol. 56, 303–308.
Peterson R. C. (2000) Mild Cognitive Impairment: transition between aging and Alzheimer’s disease. Neurologia 15, 93–101.
Schneider L., J. Olin, R. Doody, C. Clark, J. Morris, B. Reisberg, et al. and the ADCS. Validity and reliability of the Alzheimer’s disease Cooperative Study: clinical global impression of change. Alzheimer’s Dis. Assoc. Disord. 11, S22–S32.
Staubli U., Rogers G., and Lynch G. (1994a) Facilitation of glutamate receptors enhances memory. Proc. Natl. Acad. Sci. USA 91, 777–781.
Staubli U., Perez Y., Xu F., Rogers G., Ingvar M., Stone-Elander S., and Lynch G. (1994b) Centrally active modulators of glutamate receptors facilitate the induction of long-term potentiation in vivo. Proc. Natl. Acad. Sci. USA 91, 11158–11162.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Johnson, S.A., Simmon, V.F. Randomized, double-blind, placebo-controlled international clinical trial of the Ampakine® CX516 in elderly participants with mild cognitive impairment. J Mol Neurosci 19, 197–200 (2002). https://doi.org/10.1007/s12031-002-0032-4
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/s12031-002-0032-4