NCT05423522: NanoLi®_AD

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

Completed Phase 2 Last updated 17 January 2025

What this trial tests

Phase 2 trial testing NanoLithium® NP03 in Alzheimer's Disease in 72 participants. Completed in 29 October 2024.

Timeline

20 May 2022

Primary endpoint
23 January 2024

29 October 2024

Quick facts

Lead sponsor	Medesis Pharma SA
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	20 May 2022
Primary completion	23 January 2024
Estimated completion	29 October 2024
Sites	8 locations across France

Drugs / interventions tested

• NanoLithium® NP03 — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

Medesis Pharma SA — full company profile →

Who can join

Adults 50 to 90, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
2. Tau and neuroinflammation in Alzheimer's disease: interplay mechanisms and clinical translation.
   Chen Y, Yu Y. · · 2023 · cited 275× · PMID 37452321 · DOI 10.1186/s12974-023-02853-3
3. Alzheimer's disease drug development pipeline: 2024.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
4. Molecular mechanisms and therapeutic potential of lithium in Alzheimer's disease: repurposing an old class of drugs.
   Shen Y, Zhao M, Zhao P, Meng L, et al · · 2024 · cited 20× · PMID 39055498 · DOI 10.3389/fphar.2024.1408462
5. Drug Discovery and Development Targeting Dementia.
   Zagórska A, Czopek A, Fryc M, Jaromin A, et al · · 2023 · cited 18× · PMID 37259302 · DOI 10.3390/ph16020151
6. Reliability of the assessment of the clinical dementia rating scale from the analysis of medical records in comparison with the reference method.
   Dauphinot V, Calvi S, Moutet C, Xie J, et al · · 2024 · cited 17× · PMID 39238042 · DOI 10.1186/s13195-024-01567-9
7. How close is autophagy-targeting therapy for Alzheimer's disease to clinical use? A summary of autophagy modulators in clinical studies.
   Fernandes SM, Mayer J, Nilsson P, Shimozawa M. · · 2024 · cited 5× · PMID 39845082 · DOI 10.3389/fcell.2024.1520949
8. Intrinsic capacity and frailty in older adults with end-stage kidney disease undergoing pre-kidney transplant comprehensive geriatric assessment.
   Collette-Robert S, Guerville F, Novais T, Pongan E, et al · · 2024 · cited 5× · PMID 38643611 · DOI 10.1016/j.jnha.2024.100236