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This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NanoLithium® NP03 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of treatment - Adverse effects | The number and types of adverse effects during the study and causal role of the study treatment. | approximately 1 year |
| Safety of treatment - Clinical assessments - associated pathologies |
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Inclusion Criteria:
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]
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria SOTO MARTIN, Prof. | CHU Toulouse - Hôpital La Grave - Cité de la Santé | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Lille | 59037 | France | |||
| CHU de Limoges - Hôpital Dupuytren |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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Double-blind period followed by an open-label trial period. The double-blind will be maintained throughout the double-blind period treatment (except exceptional unblinding in emergency situations for reasons of patient safety).
| Placebo | Drug | 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. |
|
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.
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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) | 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]) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 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). | 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). | After 12 and 48 weeks |
| Efficacy of treatment_cognitive performances - MMSE Score | MMSE score (Units on a Scale). | After 12 and 48 weeks |
| Efficacy of treatment_cognitive performances - CDRS Score | Clinical Dementia Rating Scale (CDRS) score (Units on a Scale). | After 12 and 48 weeks |
| Efficacy of treatment_cognitive performances - ADL Score | Activity of Daily Living (ADL) score (Units on a Scale). | After 12 and 48 weeks |
| Efficacy of treatment_PET-FDG | Cerebral metabolic rate for glucose measured by Positron Emission Tomography-Fluorodeoxyglucose (PET-FDG). | After 12 and 48 weeks |
| Efficacy of treatment_Biomarkers_Peripheral biomarkers | Pathophysiological peripheral biomarkers (amyloid biomarkers, neurofilaments, Tau protein, BDNF) (pg/ml). | After 12 and 48 weeks |
| Efficacy of treatment_Biomarkers_Non-specific biomarkers | Non-specific biomarkers (inflammation cytokines). | After 12 and 48 weeks |
| Efficacy of treatment_Drug compliance | Drug compliance by assessing the number of buccal deposits. | After 12 and 48 weeks |
| Limoges |
| 87042 |
| France |
| Hôpital De La Timone | Marseille | 13005 | France |
| CHU de Montpellier - Hôpital Gui de Chauliac | Montpellier | 34295 | France |
| Hôpital Lariboisière | Paris | 75010 | France |
| Hôpital Universitaire de Strasbourg | Strasbourg | 67000 | France |
| CHU Toulouse - Hôpital La Grave - Cité de la Santé | Toulouse | 31059 | France |
| Hôpital des Charpennes - Hospices Civils de Lyon | Villeurbanne | 69100 | France |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |