NanoLi_AD

A prospective, multicenter, with a first randomised, 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

Conditions

Mild Alzheimer's dementia

Moderate Alzheimer’s dementia

Severe Alzheimer’s dementia

Sponsor

Medesis Pharma SA

Phase

Phase II

Status

Currently recruiting

Drug

NanoLithium® NP03

Countries

France

Information about the drug that will be tested in the study

Administration

Yellow oily liquid to be administrated orally in the mouth (gingivo-jugal groove of each cheek) with the pipette once daily.

Is the drug already on the market for another medical condition?

Will all participants receive the same drug?

During the first part of the study (12 weeks), participants will be selected at random to either receive one of the following options:

An oro-muccosal administration of NanoLithium® NP03 (3 mL per day & 1.8 mg/day) by a buccal deposit of 1.5mL in each cheek
An oro-muccosal administration of placebo (a substance identical in appearance to the drug being tested with no active therapeutic effect)

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

During the second part of the study (36 weeks), all participants will receive an oro-muccosal administration of NanoLithium® NP03 (3 mL per day & 1.8 mg/day) by a buccal deposit of 1.5mL in each cheek.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the safety and efficacy of NanoLithium® NP03 in people with mild-to-severe Alzheimer's disease.

How long will the treatment last?

Approximately one year.

What your involvement will entail?

During the study, participants will be asked to complete a test that will assess their dementia-related behavioral symptoms such as hallucinations, agitation (this is a test called NPI)
To complete some laboratory/biological tests (i.e. blood tests, ECG, blood pressure, pulse rate) to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
To complete other tests that will assess their neuropsychiatric symptoms, activities of daily living and memory (i.e. tests like MMSE, CDR, ADL)
Participants will be asked to undertake brain scans (PET).

A total of 18 clinical or phone call visits are scheduled during this study. Further information can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

Be 50 to 90 years old male or female
Have a diagnosis of Alzheimer’s disease according to the international diagnosis criteria from McKhann G. M. et al. (2011)
Clinical significant behavioural and psychological symptoms of dementia (BPSD) requiring medication in the opinion of the study specialist
Have a score of between 10 and 26 in the MMSE test questionnaire test (a test about your memory). This would suggest that the person has an impairment in their memory that is at a mild to severe stage
Symptomatic treatments of Alzheimer’s disease (e.g. acetylcholinesterase inhibitors and memantine) and psychotics drugs (e.g. benzodiazepines, antidepressants, anxiolytics, neuroleptics) are allowed but need to be maintained during at least 4 weeks before inclusion and during the entire study
Be willing to use contraception during the study
Have a study partner who has a sufficient and frequent contact with the participant, is willing to participate in study procedures throughout the study duration and provide accurate information regarding the patient's behavior, cognitive, and functional abilities as well as his/her health throughout the study
Be willing and able to give informed consent. If the participant is not competent, a legally authorised representative must provide informed consent on his/her behalf, and the participant must provide assent
Be 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)
Participants must be affiliated to French social security.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

Participants with genetic form of Alzheimer’s disease (known genetic mutation)
Participants with major physical or neurosensory problems likely to interfere with the tests; contraindication or refusal to perform functional brain imaging examinations
Absence of a study partner to complete psychological and behavioural scales and/or questionnaires
Participants with illiteracy and/or inability to perform psychological and behavioural evaluations
A pathology involving short term vital prognosis (e.g. progressive cancer, unstable heart failure, severe liver, kidney or respiratory diseases)
Any alcohol or drug abuse
A pregnancy or breast-feeding for female participants
Epilepsy or other neurodegenerative disorders
Vitamin B12 or folic acid deficiency without supplementation
Participation in another drug trial
Participants with thyroid disorders not treated
Participant living in institution
Participant with contraindications to drugs containing lithium such as heart failure, renal failure, Addison disease and Brugada syndrome.