Skip to main content
U.S. flag

An official website of the United States government

Chronic treatment with the gamma-secretase inhibitor LY-411575 inhibits beta-amyloid peptide production and alters lymphopoiesis and intestinal cell differentiation

Bibliographic

Year of Publication:
2004
Contact PI Name:
Eric M. Parker
Contact PI Affiliation:
Department of CNS Research, Schering-Plough Research Institute, Kenilworth, New Jersey, USA
Co-Authors:
Gwendolyn T. Wong, Denise Manfra, Frederique M. Poulet, Qi Zhang, Hubert Josien, Thomas Bara, Laura Engstrom, Maria Pinzon-Ortiz, Jay S. Fine, Hu-Jung J. Lee, Lili Zhang, Guy A. Higgins
Primary Reference (PubMED ID):
Funding Source:
Not Reported
Study Goal and Principal Findings:

Inhibition of γ-secretase, one of the enzymes responsible for the cleavage of the amyloid precursor protein (APP) to produce the pathogenic β-amyloid (Aβ) peptides, is an attractive approach to the treatment of Alzheimer disease. In addition to APP, however, several other γ-secretase substrates have been identified (e.g. Notch), and altered processing of these substrates by γ-secretase inhibitors could lead to unintended biological consequences. To study the in vivo consequences of γ-secretase inhibition, the γ-secretase inhibitor LY- 411,575 was administered to C57BL/6 and TgCRND8 APP transgenic mice for 15 days. Although most tissues were unaffected, doses of LY-411,575 that inhibited Aβ production had marked effects on lymphocyte development and on the intestine. LY-411,575 decreased overall thymic cellularity and impaired intrathymic differentiation at the CD4-CD8-CD44+CD25+ precursor stage. No effects on peripheral T cell populations were noted following LY-411,575 treatment, but evidence for the altered maturation of peripheral B cells was observed. In the intestine, LY-411,575 treatment increased goblet cell number and drastically altered tissue morphology. These effects of LY-411,575 were not seen in mice that were administered LY-D, a diastereoisomer of LY- 411,575, which is a very weak γ-secretase inhibitor. These studies show that inhibition of γ-secretase has the expected benefit of reducing Aβ in a murine model of Alzheimer disease but has potentially undesirable biological effects as well, most likely because of the inhibition of Notch processing.

Therapeutic Agent

Therapeutic Information:
Therapy Type:
Small Molecule
Therapeutic Agent:
LY-411575
Therapeutic Target:
gamma Secretase

Animal Model

Model Information:
Species:
Mouse
Model Type:
APP
Strain/Genetic Background:
C57BL/6 x C3H/He
Species:
Mouse
Model Type:
Non-transgenic
Strain/Genetic Background:
C57BL/6

Experimental Design

Is the following information reported in the study?:
Power/Sample Size Calculation
Randomized into Groups
Blinded for Treatment
Blinded for Outcome Measures
Pharmacokinetic Measures
Pharmacodynamic Measures
Toxicology Measures
ADME Measures
Biomarkers
Dose
Formulation
Route of Delivery
Duration of Treatment
Frequency of Administration
Age of Animal at the Beginning of Treatment
Age of Animal at the End of Treatment
Sex as a Biological Variable
Study Balanced for Sex as a Biological Variable
Number of Premature Deaths
Number of Excluded Animals
Statistical Plan
Genetic Background
Inclusion/Exclusion Criteria Included
Conflict of Interest

Outcomes

Outcome Measured
Outcome Parameters
Biochemical
gamma Secretase Activity
Notch Intracellular Domain (NICD)
Brain-beta Amyloid Peptide-Total
Biomarker
Plasma-beta Amyloid Peptide 40
Plasma-beta Amyloid Peptide 42
Pharmacokinetics
Drug Concentration-Plasma
Pharmacodynamics
Target Engagement (Reduction beta Amyloid Peptides-Brain)
Target Engagement (Reduction beta Amyloid Peptides-Plasma)
Toxicology
Systemic Tissue Histotoxicity