Informations générales (source: ClinicalTrials.gov)
A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory) (GREEN MEMORY)
Interventional
Phase 3
Green Valley (Shanghai) Pharmaceuticals Co., Ltd. (Voir sur ClinicalTrials)
octobre 2020
octobre 2026
29 juin 2024
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971
in mild to moderate Alzheimer's disease.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | vendredi 21 juin 2024 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Memoire Ressources - 21000 - Dijon - De Lattre De Tassigny - France | Contact (sur clinicalTrials) | ||||
| Centred Investigation Clinique - 67098 - Strasbourg - Bas Rhin - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes-Hopital Nord Laennec - 44093 - Nantes - Loire Atlantique - France | Contact (sur clinicalTrials) | ||||
| CHU Reims-Hopital Maison Blanche - 51092 - Reims - Marne - France | Contact (sur clinicalTrials) | ||||
| CHU Tours-Hopital Bretonneau - 37044 - Tonnerre - Indre Et Loire - France | Contact (sur clinicalTrials) | ||||
| CHUTimone Adultes Service - 13005 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| CMRR Paris Nord - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Pellegrin - 33076 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Hopital des Charpennes - 69100 - Villeurbanne - Rhone - France | Contact (sur clinicalTrials) | ||||
| HOPITAL Gui de CHAULIAC - 34295 - Montpellier - Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Hopitaux Civils de Colmar - 68024 - Colmar - Grand Est - France | Contact (sur clinicalTrials) | ||||
| Neurologique Pierre Wertheimer - 69677 - Bron - Rhone - France | Contact (sur clinicalTrials) | ||||
| Pharmacie CHU de Rennes - 35033 - Rennes - Ille Et Vilaine - France | Contact (sur clinicalTrials) | ||||
| Recherche Clinique Gerontopole - 31059 - Toulouse - Haute Garonne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Brain MRI scan show the highest possibility of AD.
- Have a study partner/caregiver.
- Mild to moderate AD per NIA-AA.
- History of cognitive and functional decline over at least 1 year.
- MMSE scores between 11 and 24 (inclusive) at baseline.
- Brain MRI scan show the highest possibility of AD.
- Have a study partner/caregiver.
- Diagnosis of a dementia-related central nervous system disease other than AD.
- Major structural brain disease as judged by MRI.
- A resting heart rate of < 50 beats per minute (bpm) after 5 minutes of rest in
sitting or supine position.
- Major medical illness or unstable medical condition within 6 months of screening.
- Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score,
and during the study.
- Inadequate hepatic function.
- Inadequate organ and marrow function.
- ECG clinically significant abnormalities.