NanoLi®_AD

CompletedPhase 2

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

Lead sponsor

Medesis Pharma SA

Asset

NanoLithium® NP03

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-26•Study partner/caregiver required

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2021 NanoLi-CT01

NCT IDNCT05423522

Timeline

Milestones

Study start2022-05-20actual

Study first posted2022-06-21actual

Primary completion2024-01-23actual

Study completion2024-10-29actual

Last update posted2025-01-17actual

Assets

Drug assets

NanoLithium® NP03

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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;

•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.

•If the patient took part to another therapeutic clinical trial, he/she must systematically observe a wash-out period of > 4 weeks, or of > 6 months if he/she received a biologic disease modifying treatment (antibodies targeting the β-amyloid protein or the p-Tau protein) or 5 half-lives of investigational drug(s), whichever is longer

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.

Endpoints (35)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

Global cognition

Caregiver / quality of life

Executive function / language

Amyloid biomarkers

Global cognition

2 endpoints

Secondary/protocol endpoint

Efficacy of treatment_cognitive performances - MMSE Score

Time frame:After 12 and 48 weeks

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Efficacy of treatment_cognitive performances - CDRS Score

Time frame:After 12 and 48 weeks

descriptive

Executive function / language

1 endpoint

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - cognitive signs

Time frame:approximately 1 year

descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

NPI-12 total score

Time frame:12 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Efficacy of treatment_BPSD_NPI-C-IPA

Time frame:After 12 and 48 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Efficacy of treatment_BPSD_NPI-12

Time frame:After 12 and 48 weeks

Neuropsychiatric Inventory (NPI)

descriptive

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Efficacy of treatment_Biomarkers_Peripheral biomarkers

Time frame:After 12 and 48 weeks

Neurofilament light (NfL)

descriptive

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - focal neurological signs

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - motricity

Time frame:approximately 1 year

descriptive

Safety / tolerability / PK

22 endpoints

Secondary/protocol endpoint

Safety of treatment - Adverse effects

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - associated pathologies

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - AST/ALT

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - Creatinine

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - Glomerular filtration rate

Time frame:approximately 1 year

ratio, event

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - B9 vitamin

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - B12 vitamin

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - T3

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - T4

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - biochemistry - TSH

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Hematology

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Lithium blood level

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Systolic and diastolic blood pressure

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Pulse rate

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - ECG - PR

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - ECG - QRS

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - ECG - QT

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - ECG - RR

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - ECG - QTcB

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Weight

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - Height

Time frame:approximately 1 year

descriptive

Secondary/protocol endpoint

Safety of treatment - Clinical assessments - BMI

Time frame:approximately 1 year

descriptive

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Efficacy of treatment_cognitive performances - ADL Score

Time frame:After 12 and 48 weeks

descriptive

Secondary/protocol endpoint/low confidence

Efficacy of treatment_PET-FDG

Time frame:After 12 and 48 weeks

descriptive

Secondary/protocol endpoint/low confidence

Efficacy of treatment_Biomarkers_Non-specific biomarkers

Time frame:After 12 and 48 weeks

descriptive

Secondary/protocol endpoint/low confidence

Efficacy of treatment_Drug compliance

Time frame:After 12 and 48 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.