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AMPA potentiator treatment of cognitive deficits in Alzheimer disease.
Neurology. 2007 Mar 27; 68(13):1008-12.Neur

Abstract

OBJECTIVE

To investigate the efficacy and safety of the positive alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 in patients with mild to moderate Alzheimer disease (AD) (Mini-Mental State Examination scores 14 to 26).

METHODS

One hundred eighty-one patients were randomized to treatment in an 11-week, double-blind, placebo-controlled trial. Patients received either LY451395 0.2 mg BID for 28 days and 1.0 mg BID thereafter (n = 90) or placebo (n = 91). The primary outcome measurement was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with several secondary outcome measurements: Clinician's Interview-Based Impression of Change, Trail Making Part A, Stylus Tapping Test, Single Digit Modality Test, and Neuropsychiatric Inventory (NPI).

RESULTS

Baseline demographics were similar between the two groups. Patients did not show any mean change from baseline in the ADAS-Cog after treatment with LY451395 for 4 weeks (p = 0.60) or 8 weeks (p = 0.83). The only secondary outcome measurement that showed changes from baseline compared with placebo was the NPI Total Score: p = 0.06 (marginal significance) after 4 weeks of treatment and p = 0.03 after 8 weeks of treatment. Ninety-two percent of LY451395-treated patients and 95% of placebo-treated patients completed the trial. Adverse events were experienced by 83% of LY451395-treated patients and 86% of placebo-treated patients, the majority of which were rated mild in severity.

CONCLUSION

Patients treated with LY451395 did not show a statistically significant separation from patients taking placebo on the Alzheimer's Disease Assessment Scale-Cognitive Subscale, the primary outcome measure.

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Authors+Show Affiliations

Chappell AS
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN 46285, USA. aschappell@lilly.com
Gonzales C
No affiliation info available
Williams J
No affiliation info available
Witte MM
No affiliation info available
Mohs RC
No affiliation info available
Sperling R
No affiliation info available

MeSH

AgedAged, 80 and overAlzheimer DiseaseBiphenyl CompoundsBrainCognition DisordersDouble-Blind MethodExcitatory Amino Acid AgonistsFemaleGlutamic AcidHumansMaleMiddle AgedNeuropsychological TestsPlacebosReceptors, AMPASulfonamidesSynaptic TransmissionTreatment Outcome

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17389305

Citation

Chappell, A S., et al. "AMPA Potentiator Treatment of Cognitive Deficits in Alzheimer Disease." Neurology, vol. 68, no. 13, 2007, pp. 1008-12.
Chappell AS, Gonzales C, Williams J, et al. AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Neurology. 2007;68(13):1008-12.
Chappell, A. S., Gonzales, C., Williams, J., Witte, M. M., Mohs, R. C., & Sperling, R. (2007). AMPA potentiator treatment of cognitive deficits in Alzheimer disease. Neurology, 68(13), 1008-12.
Chappell AS, et al. AMPA Potentiator Treatment of Cognitive Deficits in Alzheimer Disease. Neurology. 2007 Mar 27;68(13):1008-12. PubMed PMID: 17389305.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - AMPA potentiator treatment of cognitive deficits in Alzheimer disease. AU - Chappell,A S, AU - Gonzales,C, AU - Williams,J, AU - Witte,M M, AU - Mohs,R C, AU - Sperling,R, PY - 2007/3/29/pubmed PY - 2007/4/26/medline PY - 2007/3/29/entrez SP - 1008 EP - 12 JF - Neurology JO - Neurology VL - 68 IS - 13 N2 - OBJECTIVE: To investigate the efficacy and safety of the positive alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid modulator LY451395 in patients with mild to moderate Alzheimer disease (AD) (Mini-Mental State Examination scores 14 to 26). METHODS: One hundred eighty-one patients were randomized to treatment in an 11-week, double-blind, placebo-controlled trial. Patients received either LY451395 0.2 mg BID for 28 days and 1.0 mg BID thereafter (n = 90) or placebo (n = 91). The primary outcome measurement was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) with several secondary outcome measurements: Clinician's Interview-Based Impression of Change, Trail Making Part A, Stylus Tapping Test, Single Digit Modality Test, and Neuropsychiatric Inventory (NPI). RESULTS: Baseline demographics were similar between the two groups. Patients did not show any mean change from baseline in the ADAS-Cog after treatment with LY451395 for 4 weeks (p = 0.60) or 8 weeks (p = 0.83). The only secondary outcome measurement that showed changes from baseline compared with placebo was the NPI Total Score: p = 0.06 (marginal significance) after 4 weeks of treatment and p = 0.03 after 8 weeks of treatment. Ninety-two percent of LY451395-treated patients and 95% of placebo-treated patients completed the trial. Adverse events were experienced by 83% of LY451395-treated patients and 86% of placebo-treated patients, the majority of which were rated mild in severity. CONCLUSION: Patients treated with LY451395 did not show a statistically significant separation from patients taking placebo on the Alzheimer's Disease Assessment Scale-Cognitive Subscale, the primary outcome measure. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/17389305/AMPA_potentiator_treatment_of_cognitive_deficits_in_Alzheimer_disease_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=17389305 DB - PRIME DP - Unbound Medicine ER -