Eligibility criteria
Alzheimer’s Association criteriaThis study, decline in memory function, MCI, AD dementia
DER, POLAND
Participants were adults aged 50–80 years who had exhibited a progressive decline in memory function for >6 months before screening and had been diagnosed with either MCI due to AD or mild AD dementia according to National Institute on Aging–Alzheimer’s Association criteriaThis study was conducted in accordance with the Declaration of Helsinki and all applicable International Council for Harmonisation and Good Clinical Practice guidelines. Investigators were required to obtain ethics committee approval before beginning the study. For study sites in the USA, the study protocol was approved by Advarra’s central IRB or one of the following local ethics committees: BioMed IRB, San Diego, CA; Biomedical Research Alliance of New York, Lake Success, NY; Western IRB, Puyallup, WA; University of California, Los Angeles, Office of the Human Research Protection Program, Los Angeles, CA; Tufts Health Sciences IRB, Boston, MA; Stanford University Research Compliance Office, Palo Alto, CA; Houston Methodist IRB, Houston, TX; and Human Investigation Committee, Yale University IRB, New Haven, CT. For sites in other countries, the study protocol was approved within each respective country by the following local IRBs or ethics committees: Melbourne Health Human Research Ethics Committee (Australia); Alfred Hospital Ethics Committee (Australia); Eastern Health Research and Ethics Committee (Australia); Austin Health Human Research Ethics Committee (Australia); Comité de Protection des Personnes Ouest I (France); Ethikkommission des Fachbereichs Medizin der Ludwig-Maximilians-Universität München (Germany); Comitato Etico dell’Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo (Italy); Comitato Etico Istituzioni Ospedaliere Cattoliche (Italy); Azienda Ospedaliera Universitaria Policlinico Umberto I–Università di Roma La Sapienza (Italy); Comitato Etico IRCCS Ospedale S. Raffaele di Milano (Italy); Comitato Etico per le Sperimentazioni Cliniche della Provincia di Vicenza (Italy); Adachi Kyosai Hospital IRB (Japan); Teikyo University Hospital, Mizonokuchi IRB (Japan); Tokyo Medical University Hospital IRB (Japan); Takeda Hospital Group IRB (Japan); Koseikai Sone Clinic IRB (Japan); National Center for Geriatrics and Gerontology IRB (Japan); Osaka University Hospital IRB (Japan); Bioetyczna przy Okregowej Izbie Lekarskiej w Gdansku (Poland); Hospital Universitari i Politecnic La Fe (Spain); and Etikprövningsmyndigheten (Sweden). All participants provided written informed consent before participating in any study-related activities. An independent data monitoring committee reviewed safety data on an ongoing basis.