A prospective, multicenter, with a first part randomized, placebo-controlled, parallel-group, double-blind period followed by an open-label trial period trial to evaluate the clinical safety and efficacy of NanoLithium® NP03 in patients with moderate-to-severe Alzheimer’s disease: a proof-of-concept study - NanoLi®_AD

MEDESIS PHARMA SA0 个研究点目标入组 68 人开始时间: 2021年6月15日最近更新: 2021年10月8日

试验速览

暂无简介。

•I1) Male and female patients between 50 and 87 years of age;
•I2) Sufficient clinical and paraclinical information for the diagnosis of AD according to the international diagnosis criteria from McKhann G. M. et al. 2011;
•I3) NPI scale>2;
•I4) Patients with moderate-to-severe AD with a MMSE score from 10 and 22 included;
•I5) Symptomatic treatments of AD (acetylcholinesterase inhibitors and Memantine) and psychotics drugs (anxiolytics, thymic, neuroleptics) are allowed but need to be maintained during at least 4 weeks before inclusion and over the follow-up;
•I6) Female patient of childbearing potential must be willing to use an efficient birth control method during the study
•I7) Male patient must be willing to use male contraception (condom) during the study
•I8) Patients who have signed the informed consent form;
•I9) Patients affiliated to French social security.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 48

•E1) Patients with genetic forms of AD (known genetic mutation);
•E2) Patients with major physical or neurosensory problems likely to interfere with the tests, contraindication, or refusal to perform functional brain imaging examinations;
•E3) Pathologies involving short term vital prognosis (progressive cancer, unstable heart failure, severe liver, kidney, or respiratory diseases);
•E4) Primary chronic psychosis or psychotic episodes not associated with the AD pathology;
•E5) Absence of caregivers to complete psychological and behavioral scales and/or questionnaires;
•E6) Patients with illiteracy and inability to perform psychological and behavioral evaluations;
•E7) Pregnancy or breast-feeding;
•E8) Addiction to alcohol or drugs;
•E9) Epilepsy or others neurodegenerative disorders;
•E10) Vitamin B12 or folic acid deficiency without supplementation;
•E11) Patients participating in another drug trial;
•E12) Thyroid disorders non treated;
•E13) Patients living in institution;
•E14) Patients deprived of liberty by law or administrative decision;
•E15) Major protected by law.

发起方

MEDESIS PHARMA SA