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

Phase 1

• Conditions: Sufficient clinical and paraclinical information for the diagnosis of Alzheimer’s Disease (AD) according to the international diagnosis criteria from McKhann G. M. et al. 2011; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; MedDRA version: 20.0Level: LLTClassification code 10066571Term: Progression of Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-001273-23-FR
• Lead Sponsor: MEDESIS PHARMA SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-15
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified