Loading clinical trials...

Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease

Prospective, Multicenter, First Part Randomized, Placebo-controlled, Parallel-group, Double-blind Period Followed by Open-label Trial Period to Evaluate Clinical Safety & Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease: Proof-of-concept Study

NCT05423522•Medesis Pharma SA

View on ClinicalTrials.gov

Summary

This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).

Detailed Description

This French Study is a prospective, multicenter, randomized (1:1), placebo-controlled, parallel-group, double-blind period followed by an open-label trial period to Evaluate Clinical Safety and Efficacy of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease. Patients will be randomized into two treatment arms: * NanoLithium® NP03 (N=34) * Placebo (N=34) The first phase will consist of a double blind 12-week -period, which will be followed by an open-label 36-week period for each arm. A total of 18 clinical or phone call visits are scheduled during this study. During the follow-up, clinical, biological, electrophysiological, imaging assessments and questionnaires will be performed to determine the safety, efficacy, and disease-modifying effect of NanoLithium® NP03.

Eligibility

Age

50 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients between 50 and 90 years inclusive;
•Sufficient clinical and paraclinical information for the diagnosis of AD according to the international diagnosis criteria from McKhann G. M. et al. 2011;
•Patient presents clinically significant behavioral and psychological symptoms of dementia (BPSD) requiring medication in the opinion of the study physician (at least one item of the Neuropsychiatric Inventory-12 \[NPI-12\] with a score ≥ 4);
•Mild to-severe AD with a Minimal Mental State Examination (MMSE) score from 10 to 26 included;
•Symptomatic treatments of AD (acetylcholinesterase inhibitors and memantine) and psychotics drugs (benzodiazepines, antidepressants, anxiolytics, neuroleptics) are allowed but need to be maintained during at least 4 weeks before inclusion and during the follow-up;
•Female patient of childbearing potential must be willing to use an efficient birth control method during the study and until 5 days after the end of the treatment.
•A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus, tubal ligation).
•The following are acceptable contraceptive methods: - Established use of oral, injected, or implanted hormonal methods of contraception - Intrauterine system or placement of an intrauterine device - Double barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, cream, or suppository - True abstinence \[periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception\]
•Male patient must be willing to use male contraception (condom) during the study;
•Patient must have availability of a person ("study partner" or caregiver) who has frequent and sufficient contact with the patient, can provide accurate information regarding the patient's behavior, cognitive, and functional abilities as well as his/her health throughout the study, and agrees to provide information at investigational site visits;
+4 more criteria

Exclusion Criteria

•Patient with genetic form of AD (known genetic mutation);
•Patient with major physical or neurosensory problems likely to interfere with the tests; contraindication or refusal to perform functional brain imaging examinations;
•Absence of caregivers to complete psychological and behavioral scales and/or questionnaires;
•Patient with illiteracy and/or inability to perform psychological and behavioral evaluations;
•Pathologies involving short term vital prognosis (progressive cancer, unstable heart failure, severe liver, kidney or respiratory diseases);
•Primary chronic psychosis or psychotic episodes not associated with the AD pathology;
•Addiction to alcohol or drugs;
•Pregnancy or breast-feeding;
•Epilepsy or other neurodegenerative disorders;
•Vitamin B12 or folic acid deficiency without supplementation;
+5 more criteria

Locations (8)

CHU de Lille

Lille, France

CHU de Limoges - Hôpital Dupuytren

Limoges, France

Hôpital De La Timone

Marseille, France

CHU de Montpellier - Hôpital Gui de Chauliac

Montpellier, France

Hôpital Lariboisière

Paris, France

Hôpital Universitaire de Strasbourg

Strasbourg, France

CHU Toulouse - Hôpital La Grave - Cité de la Santé

Toulouse, France

Hôpital des Charpennes - Hospices Civils de Lyon

Villeurbanne, France

Key Dates

Start Date

May 20, 2022

Primary Completion Date

January 23, 2024

Completion Date

October 29, 2024

Last Updated

January 17, 2025

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

NanoLithium® NP03

DRUG

Placebo

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia