Alzheimer's DiseasePhase 2NanoLi®_ADNCT05423522
Clinical Safety and Efficacy Evaluation of NanoLithium® NP03 in Patients With Mild-to-severe Alzheimer's Disease
A Phase 2 study testing NanoLithium® NP03 in people with Alzheimer's Disease, run by Medesis Pharma SA at 8 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- NanoLithium® NP03
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 8 sitesFrance
- Study dates
- 20 May 2022to 29 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU de Lille
Lille, 59037
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
Hôpital De La Timone
Marseille, 13005
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Lariboisière
Paris, 75010
Hôpital Universitaire de Strasbourg
Strasbourg, 67000
CHU Toulouse - Hôpital La Grave - Cité de la Santé
Toulouse, 31059
Hôpital des Charpennes - Hospices Civils de Lyon
Villeurbanne, 69100
About this study
Official title: 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
This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).
Read the 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.
- Conditions
- Alzheimer's Disease
- Being tested
- NanoLithium® NP03, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoLithium® NP03Drug
One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
PlaceboDrug
One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
| Study group | Role | What they receive |
|---|---|---|
| NanoLithium® NP03 | Experimental | Description: Homogeneous yellow oily liquid. Dosage: One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
Duration of treatment: Approximately one year (12 weeks for the double-blind period and 36 weeks for the subsequent open-label period). Receives: Drug: NanoLithium® NP03 |
| Placebo | Placebo comparator | Description: Homogeneous yellow oily liquid. Dosage: One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette.
Duration of treatment: 12 weeks during the double-blind period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPI-12 total score
The change from baseline to end of double-blind period (W12) of the NPI-12 total score in the NanoLithium® NP03 arm and in the placebo arm.
Measured: 12 Weeks
Secondary outcomes (34)
Safety of treatment - Adverse effects
The number and types of adverse effects during the study and causal role of the study treatment.
Measured: approximately 1 year
Safety of treatment - Clinical assessments - associated pathologies
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: associated pathologies: medical conditions start and end date or ongoing, currently treated or not, recorded from patients file.
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - AST/ALT
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: AST/ALT (UI/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - Creatinine
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: Creatinine (mg/L or µmol/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - Glomerular filtration rate
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: Glomerular filtration rate -Cockcroft or MDRD method - (ml/min/1,73m2)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - B9 vitamin
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: B9 vitamin (µg/L or nmol/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - B12 vitamin
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: B12 vitamin (ng/L or pmol/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - T3
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: T3 (µg/L or nmol/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - T4
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: T4 (µg/L or nmol/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - TSH
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: biochemistry: TSH (mlU/L)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Hematology
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: hematology
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Lithium blood level
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common biological tests assessment: Clinical laboratory evaluations: lithium blood level
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Systolic and diastolic blood pressure
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Vital signs: Systolic and diastolic blood pressure (mm Hg)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Pulse rate
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Vital signs: Pulse rate (beats per minute [bpm])
Measured: approximately 1 year
Safety of treatment - Clinical assessments - ECG - PR
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Electrocardiogram (ECG): PR interval (msec)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QRS
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Electrocardiogram (ECG): QRS interval (msec)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QT
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Electrocardiogram (ECG): QT interval (msec)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - ECG - RR
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Electrocardiogram (ECG): RR interval (msec)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QTcB
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: Electrocardiogram (ECG): QTcB interval (msec)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Weight
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: General clinical examination: weight (in Kg)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - Height
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: General clinical examination: height (in cm)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - BMI
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common clinical assessment: General clinical examination: body mass index (BMI) (weight and height will be combined to report BMI in kg/m^2)
Measured: approximately 1 year
Safety of treatment - Clinical assessments - cognitive signs
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common neurological assessments: Neurological clinical examination: cognitive signs: questions asked to patients/caregiver to detect execution troubles, attention troubles, language, gnosic troubles, praxis, visuo-spacial troubles and temporo-spacial orientation
Measured: approximately 1 year
Safety of treatment - Clinical assessments - focal neurological signs
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common neurological assessments: Neurological clinical examination: focal neurological signs: questions asked to patients/caregiver to detect extrapyramidal syndrome, pyramidal syndrome, cerebellar syndrome, frontal syndrome, hallucinations, dysautonomia, sensitive system and epilepsy
Measured: approximately 1 year
Safety of treatment - Clinical assessments - motricity
To assess the safety of NanoLithium® NP03 after 48 weeks of treatment based on common neurological assessments: Neurological clinical examination: motricity: questions asked to patients/caregiver to detect muscular tonus, abnormal movements, reflex, walking troubles, falls, postural troubles, coordination, sphincter and trophic troubles
Measured: approximately 1 year
Efficacy of treatment_BPSD_NPI-C-IPA
To assess the BPSD at 12 and 48 weeks, change from baseline to week 12 and week 48 on the Neuropsychiatric Inventory - Clinician items mapped to International Psychogeriatric Association (NPI-C-IPA) scale (Units on a Scale).
Measured: After 12 and 48 weeks
Efficacy of treatment_BPSD_NPI-12
To assess the BPSD at 12 and 48 weeks, score of each item of the Neuropsychiatric Inventory (NPI-12) (Units on a Scale).
Measured: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - MMSE Score
MMSE score (Units on a Scale).
Measured: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - CDRS Score
Clinical Dementia Rating Scale (CDRS) score (Units on a Scale).
Measured: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - ADL Score
Activity of Daily Living (ADL) score (Units on a Scale).
Measured: After 12 and 48 weeks
Efficacy of treatment_PET-FDG
Cerebral metabolic rate for glucose measured by Positron Emission Tomography-Fluorodeoxyglucose (PET-FDG).
Measured: After 12 and 48 weeks
Efficacy of treatment_Biomarkers_Peripheral biomarkers
Pathophysiological peripheral biomarkers (amyloid biomarkers, neurofilaments, Tau protein, BDNF) (pg/ml).
Measured: After 12 and 48 weeks
Efficacy of treatment_Biomarkers_Non-specific biomarkers
Non-specific biomarkers (inflammation cytokines).
Measured: After 12 and 48 weeks
Efficacy of treatment_Drug compliance
Drug compliance by assessing the number of buccal deposits.
Measured: After 12 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start20 May 2022
- Primary completion23 Jan 2024
- Study completion29 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 mild-to-severe Alzheimer's disease: a proof-of-concept study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medesis Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria SOTO MARTIN, Prof., Principal investigator, CHU Toulouse - Hôpital La Grave - Cité de la Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423522
- Sponsor's protocol ID
- 2021 NanoLi-CT01
- Acronym
- NanoLi®_AD
- Status last verified
- Jan 2025
- First submitted
- 15 Apr 2022
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05423522
- Acronym / sponsor ID
- NanoLi®_AD / 2021 NanoLi-CT01
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medesis Pharma SAIndustry (pharma, biotech, devices)
- Study start
- 20 May 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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 mild-to-severe Alzheimer's disease: a proof-of-concept study.
| Arm | Type | Receives |
|---|---|---|
| NanoLithium® NP03 | Experimental | Drug: NanoLithium® NP03Description: Homogeneous yellow oily liquid. Dosage: One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette. Duration of treatment: Approximately one year (12 weeks for the double-blind period and 36 weeks for the subsequent open-label period). |
| Placebo | Placebo comparator | Drug: PlaceboDescription: Homogeneous yellow oily liquid. Dosage: One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette. Duration of treatment: 12 weeks during the double-blind period. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoLithium® NP03One administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette. | Drug | NanoLithium® NP03 |
| PlaceboOne administration of 3 mL per day (1.8 mg/day) by depositing 1.5 mL in the gingivo-jugal groove of each cheek with the graduated pipette. | Drug | Placebo |
Primary outcome
NPI-12 total score
Time frame: 12 Weeks
The change from baseline to end of double-blind period (W12) of the NPI-12 total score in the NanoLithium® NP03 arm and in the placebo arm.
34 secondary outcomes
Safety of treatment - Adverse effects
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - associated pathologies
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - AST/ALT
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - Creatinine
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - Glomerular filtration rate
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - B9 vitamin
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - B12 vitamin
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - T3
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - T4
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - biochemistry - TSH
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Hematology
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Lithium blood level
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Systolic and diastolic blood pressure
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Pulse rate
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - ECG - PR
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QRS
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QT
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - ECG - RR
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - ECG - QTcB
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Weight
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - Height
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - BMI
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - cognitive signs
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - focal neurological signs
Time frame: approximately 1 year
Safety of treatment - Clinical assessments - motricity
Time frame: approximately 1 year
Efficacy of treatment_BPSD_NPI-C-IPA
Time frame: After 12 and 48 weeks
Efficacy of treatment_BPSD_NPI-12
Time frame: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - MMSE Score
Time frame: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - CDRS Score
Time frame: After 12 and 48 weeks
Efficacy of treatment_cognitive performances - ADL Score
Time frame: After 12 and 48 weeks
Efficacy of treatment_PET-FDG
Time frame: After 12 and 48 weeks
Efficacy of treatment_Biomarkers_Peripheral biomarkers
Time frame: After 12 and 48 weeks
Efficacy of treatment_Biomarkers_Non-specific biomarkers
Time frame: After 12 and 48 weeks
Efficacy of treatment_Drug compliance
Time frame: After 12 and 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria SOTO MARTIN, Prof. principal investigator
CHU Toulouse - Hôpital La Grave - Cité de la Santé
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NanoLithium® NP03 in people with Alzheimer's Disease, run by Medesis Pharma SA at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPI-12 total score (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.