Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001273-23
    Sponsor's Protocol Code Number:2021NanoLi-CT01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2021-001273-23
    A.3Full title of the trial
    A prospective, multicenter, with a first part randomized, placebo-controlled, parallel-group, double-blind period followed by an open-label trial period trial to evaluate the clinical safety and efficacy of NanoLithium® NP03 in patients with moderate-to-severe Alzheimer’s disease: a proof-of-concept study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    NanoLi®_AD
    A.4.1Sponsor's protocol code number2021NanoLi-CT01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMEDESIS PHARMA SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMEDESIS Pharma SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEDESIS Pharma SA
    B.5.2Functional name of contact pointChief Executive Officer
    B.5.3 Address:
    B.5.3.1Street AddressL'Orée des Mas, Avenue du golf
    B.5.3.2Town/ cityBaillargues–Montpellier
    B.5.3.3Post code34670
    B.5.3.4CountryFrance
    B.5.4Telephone number33467030396
    B.5.6E-mailjc-maurel@medesispharma.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNanoLithium® NP03
    D.3.4Pharmaceutical form Oral emulsion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral emulsion
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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
    E.1.1.1Medical condition in easily understood language
    moderate-to-severe Alzheimer’s Disease (AD)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066571
    E.1.2Term Progression of Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective (at 12 weeks):
    To evaluate the clinical efficacy of NanoLithium® NP03 versus placebo, on the progression of the behavioral and psychological symptoms of dementia (BPSD) between baseline and after 12 weeks of treatment in patients with moderate-to-severe AD.
    E.2.2Secondary objectives of the trial
    Secondary objectives (at 12 weeks, after the double-blind phase and at 48 weeks, after the open label 36-week phase):
    - To assess the clinical safety of NanoLithium® NP03 during 48 weeks in patients with AD from moderate-to-severe AD.
    - To evaluate the efficacy of NanoLithium® NP03 on:
    - the progression of the cognitive performances,
    - the progression of the BPSD,
    - the progression of the cortical hypometabolism in parieto-temporal regions.
    - To determine the potential disease-modifying effect of the NanoLithium® NP03 on the progression of AD pathophysiological biological peripheral biomarkers (amyloid, neurofilaments, Tau biomarkers, BNDF in plasma) and non-specific biomarkers (inflammation cytokines measured with cytokines assays).
    - To assess the effect of NanoLithium® NP03 on the progression of sleep/wake cycles.
    - To assess treatment compliance.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the change from baseline to end of double-blind period (W12) of the NPI score in the NanoLithium® NP03 arm and in the placebo arm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NPI score
    E.5.2Secondary end point(s)
    Secondary safety endpoints will be:
    - The number and types of adverse effects during the study and causal role of the study treatment
    - To assess the safety of the NanoLithium® NP03 after 48 weeks of treatment on common biological tests, clinical and neurological assessments

    Secondary efficacy endpoints will be assessed after 12 weeks of treatment (end of the double-blind period), and after 48 weeks of treatment (end of open-label period). The following endpoints will be used:
    - Behavioral and psychosocial troubles
    - Cognitive performances
    - Cerebral metabolic rate for glucose measured by the PET-FDG
    - Pathophysiological peripheral biomarkers (amyloid biomarkers, neurofilaments, Tau protein, BDNF) and non-specific biomarkers
    - Actigraphy-sleep/wake measures (sleep duration, sleep efficacy, daytime activity) and score of sleep/wake questionnaires
    - Drug treatment compliance will be assessed by the number of buccal deposits
    E.5.2.1Timepoint(s) of evaluation of this end point
    - To assess the safety of the NanoLithium® NP03 after 48 weeks of treatment on common biological tests, clinical and neurological assessments:
    o Associated pathologies
    o Clinical laboratory evaluation: biochemistry, hematology, lithium blood levels
    o Vital signs: hear rate, diastolic blood pressure, systolic blood pressure
    o ECG
    o General clinical examination: weight, height, Body Mass Index (BMI)
    o Neurological clinical examination: cognitive signs, focal neurological signs, motricity

    - Behavioral and psychosocial troubles:
    o NPI-NH score
    o BDI score
    o Apathic score


    - Cognitive performances
    o MMSE score
    o Isaacs Set Test score
    o Trail Making Test A and B score
    o ADAS-Cog score
    o CDR score
    o IADL score
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 48
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state68
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-10-29
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri May 02 02:06:51 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA