Last updated on April 2018

Study of LM11A-31-BHS in Mild-moderate AD Patients


Brief description of study

The purpose of this study is to determine the safety of 2 doses of LM11A-31-BHS in 180 patients with Alzheimer's Disease versus placebo and to access biomarker and clinical exploratory endpoints of LM11A-31-BHS

Detailed Study Description

The goal of this AD Pilot is to conduct a prospective, double-blind, multicenter, phase IIa exploratory safety, feasibility and proof-of-concept trial in mild to moderate Alzheimer's disease patients with the orally bioavailable p75 neurotrophin receptor ligand LM11A-31-BHS dosed twice daily for 26 weeks. Successful completion of this trial will provide the safety, endpoint and statistical basis for the design and execution of a phase 2b/3 efficacy trial. It will also bring to the AD field a much-needed new set of target mechanisms and will help pioneer the strategy of the concomitant targeting of multiple fundamental AD-related pathological processes.

During the 26 weeks study period the eligible patients will be invited to 5 visits.

Safety monitoring will include the full extent of phase 2 clinical, electrophysiological and laboratory testing.

Clinical Study Identifier: NCT03069014

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Reinhold Schmidt, Prof. Dr.

University Hospital Graz
Graz, Austria
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Douglas Imarhiagbe, OA Dr. med.

Landeskrankenhaus Hall
Hall in Tirol, Austria
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Jakub Hort, Prof. MD

Charles University
Praha, Czech Republic
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Katerina Sheardová, MD

Neurology Clinic of Martin Urbanek
Brno, Czech Republic
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Ladislav Pazdera, MD

Vestra clinics s.r.o
Rychnov nad Kneznou, Czech Republic
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Martin Valis, MD

NEUROHK s.r.o
Chocen, Czech Republic
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Joachim Springub, Dr. med.

Studienzentrum Nordwest
Westerstede, Germany
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Peter Schönknecht, Prof. Dr.

S chsisches Krankenhaus Arnsdorf
Arnsdorf, Germany
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Ralf Bodenschatz, Dipl.-med.

Pharmakologisches Studienzentrum Chemnitz GmbH
Chemnitz, Germany
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Oliver Peters, Doz. Dr.

Charit Universit tsmedizin Berlin
Berlin, Germany
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Niels Andreasen, Prof.Dr.

Karolinska University
Stockholm, Sweden
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Pawel Kermer, Prof.Dr.med

Nordwestkrankenhaus Sanderbusch
Sande, Germany
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Irma Schöll, MD

Zentrum f r klinische Forschung
Bad Homburg, Germany
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Daniel Bittner, MD

Universit tsklinik Magdeburg, Klinik f r Neurologie
Magdeburg, Germany
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Andrej Pauls, Dipl.Psy.MD

Neurologie Sendlinger Strasse Studien- und Ged chtniszentrum M nchen
München, Germany
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Robert Perneczky, Prof. MD

LMU M nchen Klinik f r Psychiatrie und Psychotherapie
München, Germany
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Mercé Boada Rovira, MD

Fundaci ACE
Barcelona, Spain
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Rafael Blesa González, MD

Fundaci n de Gesti n Sanitaria del Hospital de la Santa Creu I Sant Pau, C
Barcelona, Spain
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Raquel Sánchez del Valle, MD

Hospital Cl nic de Barcelona
Barcelona, Spain
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Ana Frank García, Prof. MD.

Hospital la Paz
Madrid, Spain
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Emilio Franco Macías, MD

Hospital Virgen del Roc o
Sevilla, Spain
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Recruitment Status: Open


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