NCT05423522已完成2 期
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
Medesis Pharma SA8 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 8
- 主要终点
- NPI-12 total score
研究概览
简要总结
This proof-of-concept study will assess safety, tolerance, and efficacy of NanoLithium® NP03 in patients with mild-to-severe Alzheimer's Disease (AD).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: NanoLithium® NP03 (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
NPI-12 total score
时间窗: 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.
次要结局
- Efficacy of treatment_Biomarkers_Non-specific biomarkers(After 12 and 48 weeks)
- Safety of treatment - Clinical assessments - Weight(approximately 1 year)
- Safety of treatment - Clinical assessments - Height(approximately 1 year)
- Safety of treatment - Clinical assessments - BMI(approximately 1 year)
- Safety of treatment - Clinical assessments - cognitive signs(approximately 1 year)
- Efficacy of treatment_BPSD_NPI-C-IPA(After 12 and 48 weeks)
- Efficacy of treatment_Biomarkers_Peripheral biomarkers(After 12 and 48 weeks)
- Safety of treatment - Clinical assessments - associated pathologies(approximately 1 year)
- Efficacy of treatment_PET-FDG(After 12 and 48 weeks)
- Safety of treatment - Adverse effects(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - B9 vitamin(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - AST/ALT(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - Creatinine(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - Glomerular filtration rate(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - B12 vitamin(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - T3(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - T4(approximately 1 year)
- Safety of treatment - Clinical assessments - biochemistry - TSH(approximately 1 year)
- Safety of treatment - Clinical assessments - Hematology(approximately 1 year)
- Safety of treatment - Clinical assessments - Lithium blood level(approximately 1 year)
- Safety of treatment - Clinical assessments - Systolic and diastolic blood pressure(approximately 1 year)
- Safety of treatment - Clinical assessments - Pulse rate(approximately 1 year)
- Safety of treatment - Clinical assessments - ECG - PR(approximately 1 year)
- Safety of treatment - Clinical assessments - ECG - QRS(approximately 1 year)
- Safety of treatment - Clinical assessments - ECG - QT(approximately 1 year)
- Safety of treatment - Clinical assessments - ECG - RR(approximately 1 year)
- Safety of treatment - Clinical assessments - ECG - QTcB(approximately 1 year)
- Safety of treatment - Clinical assessments - focal neurological signs(approximately 1 year)
- Safety of treatment - Clinical assessments - motricity(approximately 1 year)
- Efficacy of treatment_cognitive performances - MMSE Score(After 12 and 48 weeks)
- Efficacy of treatment_BPSD_NPI-12(After 12 and 48 weeks)
- Efficacy of treatment_cognitive performances - CDRS Score(After 12 and 48 weeks)
- Efficacy of treatment_cognitive performances - ADL Score(After 12 and 48 weeks)
- Efficacy of treatment_Drug compliance(After 12 and 48 weeks)
研究者
研究点 (8)
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