Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
EIP Pharma Inc
Age
60–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 60 - 85 (inclusive)
Willing and able to provide informed consent
Clinical presentation consistent with MCI due to AD or of mild AD
* Gradual progressive decline in memory function over \>6 months
* Amnestic presentation on neuropsychological testing with rapid forgetting (% reduction 1.5 standard deviations below the mean)
* Clinical Dementia Rating (CDR) Sum of Box (SOB) score ≥0.5
* Mini-Mental State Examination (MMSE) range: 20 to 30
Brain hypometabolism by 18F-2-fluoro-2-deoxyglucose (FDG)-PET
Participants may be taking medications for AD, provided that the dose of these medications has been stable for \>3 months.
You may not be if
Evidence of neurodegenerative disease other than AD
Inability for any reason to undergo MRI scans (e.g. pacemaker, vascular stent or stent graft). 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 (\<90 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
Donation of \>500 mL of blood or blood products within 2 months
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
