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

• Status: Recruiting
• Trial end date: 2024-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medesis Pharma SA

Criteria

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;

• 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;

• Patient is willing and able to give informed consent. If the study patient is not competent, a legally authorized representative must provide informed consent on his/her behalf, and the patient must provide assent;

• Patient affiliated to French social security;

• Patient is willing to and can comply with the study protocol requirements, in the opinion of the investigator.

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;

• Patient participating in another drug trial;

• Thyroid disorders not treated;

• Patient living in institution;

• Patient deprived of liberty by law;

• Patient with contraindications to drugs containing lithium: heart failure, renal failure, Addison disease, and Brugada syndrome.