Effects of liraglutide on neurodegeneration, blood flow and cognition in Alzheimer's disease - protocol for a controlled, randomized double-blinded trial

Lærke Egefjord*, Michael Gejl, Arne Møller, Hans Brændgaard, Hanne Gottrup, Olga Antropova, Niels Møller, Henrik E Poulsen, Albert Gjedde, Birgitte Brock, Jørgen Rungby

*Kontaktforfatter for dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Abstrakt

INTRODUCTION: Type 2 diabetes (DM-2) increases the risk of developing Alzheimer´s disease (AD), and patients with AD are more likely to develop DM-2. DM-2 and AD share some pathophysiological features. In AD, amyloid-β (Aβ) is accumulated as extracellular plaques in the gray matter of the brain, while in DM-2 islet amyloid polypeptide (IAPP) is accumulated in the pancreas. Premature cellular degeneration is seen in both diseases. Glucagon-like peptide-1 (GLP-1) reduces the amount of Aβ and improves cognition in animal studies. The present study tests the hypothesis that treatment with the long-acting GLP-1 receptor agonist liraglutide affects the accumulation of Aβ in patients with AD.

MATERIAL AND METHODS: This is a randomized, controlled, double-blinded intervention study with AD patients treated for six months with liraglutide (n = 20) or placebo (n = 20). The primary outcome is change in deposition of Aβ in the central nervous system (CNS) by Pittsburgh compound B positron emission tomography (PET). The secondary outcome is evaluation of cognition using a neuro-psychological test battery, and examination of changes in glucose uptake in the CNS by 18F-fluoro-deoxy-glucose PET. Finally, a perfusion-weighted magnetic resonance imaging with contrast will be performed to evaluate blood flow.

CONCLUSION: No registered drug affects the deposition of Aβ in the brain of AD patients. Our goal is to find a new therapeutic agent that alters the pathophysiology in AD patients by decreasing the formation of Aβ plaques and thereby presumably improves the cognitive function.

FUNDING: The trial is investigator-initiated and investigator-driven and is supported by Novo Nordisk Scandinavia.

TRIAL REGISTRATION: ClinicalTrials.gov: NCT01469351.

OriginalsprogEngelsk
ArtikelnummerA4519
TidsskriftDanish Medical Journal
Vol/bind59
Udgave nummer10
Antal sider4
ISSN1603-9629
StatusUdgivet - okt. 2012
Udgivet eksterntJa

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