A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: Early Alzheimer's Disease
Age: Between 50 - 90 Years
Gender: Male or Female
Inclusion Criteria includes:
Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; must be corroborated by an informant.
Male or female subjects aged greater than or equal to 50 and less than or equal to 90 years, at the time of informed consent.
MMSE score greater than or equal to 22 at Screening and Baseline and less than or equal to 30 at Screening and Baseline.
Body mass index (BMI) greater than 17 and less than 35 at Screening.
Have an identified study partner (defined as a person able to support the subject for the duration of the study and who spends at least 8 hours per week with the subject). The study partner must provide separate written informed consent. In addition, this person must be willing and able to provide follow-up information on the subject throughout the course of the study. This person must, in the opinion of the investigator, spend sufficient time with the subject on a regular basis such that the study partner can reliably fulfill the study requirements. A permanent study partner need not be living in the same residence with the subject. For such a study partner not residing with the subject, the investigator has to be satisfied that the subject can contact the study partner readily during the times when the study partner is not with the subject. if in doubt about whether a subject's care arrangements are suitable for inclusion, the investigator should discuss this with the medical monitor. Study partners need to participate in person for visits where clinical assessment of CDR (global and CDR-SB), EQ-5D-5L, QOL-AD, ADCS MCI-ADL, and Zarit Burden Interview take place.
Exclusion Criteria includes:
1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [B-hCG] or human chorionic gonadotropin [hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of B-hCG [or hCG]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more then 72 hours before the first dose of study drug.
2. Females of childbearing potential who:
-Within 28 days before study entry, did not use a highly effective method of contraception, which includes any of the following:
-total abstinence (if it is their preferred and usual lifestyle)
-an intrauterine device or intrauterine hormone-releasing system (IUS)
-a contraceptive implant
-an oral contraceptive (with additional barrier method) (Subject must be on a stable dose of the same oral contraceptive product for at least 28 days before dosing and throughout the study and for 28 days after study drug discontinuation.)
-have a vasectomized partner with confirmed azoospermia
-do not agree to use a highly effective method of contraception (as described above) throughout the entire study period and for 28 days after study drug discontinuation
-for sites outside of the EU, it is permissible that if a highly effective method of contraception is not appropriate or acceptable method of contraception, ie, double-barrier methods of contraception such as latex or synthetic condom plus diaphragm or cervical/vault cap with spermicide
3. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the subject's AD.
4. History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening.
5. Any psychiatric diagnosis or symptoms, (eg, hallucinations, major depression, or delusions) that could interfere with study procedures in the subject.
6. GDS score greater than or equal to 8 at Screening.
Contact the research team to learn more about this study.
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