phase III alzheimer pas encore lancée

Source: Merci Hypokrat

L'étude de phase III dans Alzheimer: info officielle


Une étude de phase III du masitinib à été officiellement déclarée en 2010.
Sources:
répertoire de
l'OMS.
http://apps.who.int/trialsearch/Trial.aspx?TrialID=EUCTR2010-021218-50-F R

Et répertoire européen
:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number: 2010-021218-50

Détails :
https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-021218-50/FR

Prin cipales caractéristiques:

Étude de phase III multicentrique, en double- aveugle, controlée par un placebo,randomisée, en groupes parallèles, pour évaluer la tolérance et l efficacité du masitinib chez des malades souffrant d'Alzheimer faible à modéré.
Code de l étude (interne à AB Science): AB09004
Nombre de malades prévu: 300 dont 250 dans l'Union Européenne
Âge des malades: 100 malades de 18 à 64 ans et 200 de plus de 65 ans.
Pays prévus (nombre de malades)
République Tchèque
France (50)
Allemagne
Roumanie
Slovaquie
Espagne (60)
États-unis
Durée de suivi prévue: 24 semaines (6mois) d après objectifs décrits et document de formation
(diapos7):
http://www.ab-science.com/ab09004training/pdf/AB-Science-2011.pdf


Info Entrée dans répertoire européen: 15 juillet 2010
Accord du Comité d'éthique: septembre 2010
Date de début (premier recrutement de malades): 25 mai 2011

Statut de médicament orphelin dans l indication: non

Statut : pas en phase de recrutement
(NB: ne précise pas si recrutement achevé ou suspendu).

source : search O.lenoir

Alzheimer en espagne:
La ph3 alzheimer en Espagne: http://www.idipaz.es/PaginaDinamica.aspx?IdPag=49&Lang=ES

Masitinib as an adjunct therapy for mild-to-moderate Alzheimer's disease: a randomised, placebo-controlled phase 2 trial.

Piette F, Belmin J, Vincent H, Schmidt N, Pariel S, Verny M, Marquis C, Mely J, Hugonot-Diener L, Kinet JP, Dubreuil P, Moussy A, Hermine O.
Source
Hôpital Charles Foix, Service de Médecine, Bâtiment Louis Ramond, 7 avenue de la République, 94205 Ivry-Sur-Seine, France. francois.piette@cfx.aphp.fr.
Abstract
INTRODUCTION:
Neuroinflammation is thought to be important in Alzheimer's disease pathogenesis. Mast cells are a key component of the inflammatory network and participate in the regulation of the blood-brain barrier's permeability. Masitinib, a selective oral tyrosine kinase inhibitor, effectively inhibits the survival, migration and activity of mast cells. As the brain is rich in mast cells, the therapeutic potential of masitinib as an adjunct therapy to standard care was investigated.
METHODS:
A randomised, placebo-controlled, phase 2 study was performed in patients with mild-to-moderate Alzheimer's disease, receiving masitinib as an adjunct to cholinesterase inhibitor and/or memantine. Patients were randomly assigned to receive masitinib (n = 26) (starting dose of 3 or 6 mg/kg/day) or placebo (n = , administered twice daily for 24 weeks. The primary endpoint was change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-Cog) to assess cognitive function and the related patient response rate.
RESULTS:
The rate of clinically relevant cognitive decline according to the ADAS-Cog response (increase >4 points) after 12 and 24 weeks was significantly lower with masitinib adjunctive treatment compared with placebo (6% vs. 50% for both time points; P = 0.040 and P = 0.046, respectively). Moreover, whilst the placebo treatment arm showed worsening mean ADAS-Cog, Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory, and Mini-Mental State Examination scores, the masitinib treatment arm reported improvements, with statistical significance between treatment arms at week 12 and/or week 24 (respectively, P = 0.016 and 0.030; P = 0.035 and 0.128; and P = 0.047 and 0.031). The mean treatment effect according to change in ADAS-Cog score relative to baseline at weeks 12 and 24 was 6.8 and 7.6, respectively. Adverse events occurred more frequently with masitinib treatment (65% vs. 38% of patients); however, the majority of events were of mild or moderate intensity and transitory. Severe adverse events occurred at a similar frequency in the masitinib and placebo arms (15% vs. 13% of patients, respectively). Masitinib-associated events included gastrointestinal disorders, oedema, and rash.
CONCLUSIONS:
Masitinib administered as add-on therapy to standard care during 24 weeks was associated with slower cognitive decline in Alzheimer's disease, with an acceptable tolerance profile. Masitinib may therefore represent an innovative avenue of treatment in Alzheimer's disease. This trial provides evidence that may support a larger placebo-controlled investigation.
TRIAL REGISTRATION:
Clinicaltrials.gov NCT00976118.
PMID: 21504563 [PubMed] PMCID: PMC3226277 Free PMC Article