Status:
COMPLETED
Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Fondation Plan Alzheimer
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
For this project, neflamapimod and placebo will be provided free of charge by the EIP company (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in Europe (The Nethe...
Detailed Description
The present project is an intervention proof of concept study to test the efficacy of neflamapimod in a population of AD patients at an early stage. To track the impact of this drug in patients, the ...
Eligibility Criteria
Inclusion
- A group of 40 AD patients at an early stage (prodromal) will be recruited. Patient's recruitment will follow the most recent research criteria for AD in its "typical form" (Dubois, Feldman et al. 2014):
- Age 50 - 90 (inclusive)
- Willing and able to provide informed consent
- Objective memory impairment corroborated by level of performance on a standardized memory test (Free and Cued Selective Reminding test, (Grober, Hall et al. 2008)) \< -1.5 DS according to established norms and
- Documented cerebral amyloidopathy using CSF analysis or PET amyloid imaging and
- Early stage of the disease (Mini Mental State Examination \> 20) (Folstein, Robins et al. 1983).
Exclusion
- • Evidence of neurodegenerative disease other than AD
- Inability for any reason to undergo MRI scans (e.g. pacemaker). Patients who require sedation for screening procedures such as MRI may receive a short-acting sedative.
- Psychiatric disorder that would compromise ability to comply with study requirements
- History of cancer within the last 5 years, except basal cell carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with no significant progression over the past 2 years
- Significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder or metabolic/endocrine disorders or other disease that would preclude treatment with p38 MAP kinase inhibitor and/or assessment of drug safety and efficacy
- Recent (\<60 days) changes to AD medications prescribed for cognitive reasons or with the potential to impact cognition
- Psychotropic drugs taken within 1 month. Anticoagulant drugs taken within 1 week.
- Participation in a study of an investigational drug less than 6 months or 5 half-lives of the investigational drug, whichever is longer, before enrollment in the study
- Male subjects with female partner of child-bearing potential who are unwilling or unable to adhere to contraception requirements
- Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingoophorectomy
- Positive urine or serum pregnancy test or plans desires to become pregnant during the course of the trial
- History of alcohol and/or illicit drug abuse within 6 months.
- Infection with hepatitis A, B or C or HIV.
- Any factor deemed by the investigator to be likely to interfere with study conduction
Key Trial Info
Start Date :
October 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03435861
Start Date
October 8 2018
End Date
June 30 2021
Last Update
June 22 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Toulouse
Toulouse, France, 31000