Actively Recruiting
Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD
Led by Centre Hospitalier St Anne · Updated on 2024-06-12
45
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier St Anne
Lead Sponsor
F
For Drug Consulting
Collaborating Sponsor
AI-Summary
What this Trial Is About
Study aims at evaluating the therapeutic efficacy and safety of low-dose IL-2 immunomodulatory treatment in patients with early AD, in a phase II, randomized, double blind, placebo-controlled phase II clinical trial. Patients with AD at early stage will be recruited and randomized (2:1) in each treatment group. The primary endpoint is the rate of decline assessed through CDR change at 18 months between the placebo group and the treated patients.
CONDITIONS
Official Title
Therapeutic Evaluation of Low-dose IL-2-based Immunomodulatory Approach in Patients With Early AD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged > 18 years
- Disease onset before 70 years of age
- Clinical diagnosis of progressive amnestic syndrome with or without other cognitive impairments
- Cerebrospinal fluid biomarkers suggestive of Alzheimer's disease
- Brain MRI consistent with diagnosis as judged by investigator
- Clinical Dementia Rating Scale score of 0.5 or 1
- Stable doses of antidepressant or acetylcholinesterase inhibitors for at least 1 month if applicable
- Have a caregiver who provides separate written informed consent; replacement caregiver allowed if needed
- Adequate vision and hearing for neuropsychological testing as determined by investigator
- Written informed consent approved by ethical review board
- French social security number and fluency in French
You will not qualify if you...
- Unstable or progressive psychiatric disorders
- Severe or unstable medical conditions interfering with evaluation
- History of epilepsy
- Under legal guardianship or curatorship
- Contraindications to MRI
- History of severe alcoholism or drug misuse within past 5 years
- Vascular, inflammatory, or expansive brain lesions visible on MRI affecting diagnosis
- No health insurance
- Women of childbearing potential (fertile women not permanently sterilized or postmenopausal)
- History of autoimmune disease
- History of malignant disease within past 10 years
- Other causes of dementia including other neurodegenerative diseases
- Renal dysfunction with clearance < 30 mL/min
- Chronic liver disease indicated by abnormal liver tests
- Abnormal thyroid function
- Participation in therapeutic trials involving immunization against amyloid within past year if assigned active treatment
- Active viral infections (CMV, EBV, HCV, HBV, TPHA-VDRL, HIV)
- Severe heart disease or dysfunction in vital organs
- Low white blood cell count (< 4000/mm3), low platelets (< 100000/mm3), or low hematocrit (< 30%)
- Abnormal bilirubin or creatinine levels
- Organ transplant recipients
- Likely need for corticosteroid treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
GHU Saint Anne
Paris, France, 75674
Actively Recruiting
Research Team
K
Khaoussou SYLLA, Dr
CONTACT
V
Viviane AWASSI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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