IL-2-AD

Therapeutic evaluation of low-dose IL-2-based immunomodulatory approach in patients with early Alzheimer's disease

Conditions

Sponsor

Centre Hospitalier St Anne

Phase

Status

Drug

IL-2 (PROLEUKIN ®)

Countries

France

The drug will be administered via a subcutaneous injection (an injection under the skin).

Yes - indicated for the treatment of adults with metastatic renal cell carcinoma and metastatic melanoma.

Participants will be selected at random to either receive one of the following options:

A subcutaneous injection of IL-2
A subcutaneous injection of placebo (also called a dummy treatment which is an inactive 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.

The purpose of the study is to evaluate the safety and efficacy of low-dose IL-2 in people with early Alzheimer’s disease.

The treatment consists of 21 cures of subcutaneous injections of either placebo or IL-2
Participants will receive 5 consecutive injections during the induction phase which will be followed by a week break. During the maintenance phase a total of 16 injections will be administered weekly
The total duration of treatment for each participant is anticipated to be 18 weeks. Participants will be followed-up for 18 months after the first injection.

During the study, participants will be asked to complete tests that will assess their memory, functioning and cognition (i.e. tests like MMSE, CDR-SB, ADAS-Cog)
Participants will be asked to undertake brain scans (PET, MRI)
To complete some laboratory/biological tests (i.e. blood tests, blood pressure, weight, temperature, ECG) to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

Further information on the procedures, tests and number of visits can be obtained from the study team.

To take part in the study, participants must:

Have >18 years old
Have an age of disease onset above 70 years
Have a diagnosis of Alzheimer's disease
Have evidence of abnormal accumulation of amyloid in their brain (MRI)
Have a score of 0.5 or 1 in the Clinical Dementia Rating-Global Score (CDR). This would suggest that the person has an impairment in its memory that is at a mild stage
If the person is taking antidepressant or approved symptomatic medication for dementia (i.e. donepezil, rivastigmine, galantamine or memantine) the dosing regimen must have been stable for at least 3 months prior to the baseline visit
Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
Have a French social security number and be fluent in French.

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

A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g., psychiatric symptoms, epilepsy, renal dysfunction, Chronic hepatic diseases, clinically significant abnormalities of thyroid function)
Any alcohol or drug abuse
Women of childbearing potential
Diagnosis or history of other neurodegenerative diseases such as Parkinson’s disease, Huntington disease, Lewy Bodies Dementia, Frontotemporal dementia)
Positive HIV test or Active hepatitis B and/or C.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.