A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease
A Placebo-Controlled, Double-Blind, Parallel-Group, 24 Month Study With an Open-Label Extension Phase to Evaluate the Efficacy and Safety of Elenbecestat (E2609) in Subjects With Early Alzheimer's Disease
The name of this trial is MissionAD1. This phase 3 study consists of a Core and Open Label Extension (OLE) Phase in participants with Early Alzheimer's Disease (EAD), and will be conducted to evaluate the efficacy and safety of E2609. The Core is a 24-month treatment, multicenter, double blind, placebo controlled parallel group study. The OLE is a 24-month treatment, one group study. The data for the studies E2609-G000-301 (NCT02956486, MissionAD1) and E2609-G000-302 (NCT03036280, MissionAD2) will be pooled.
Inclusion Criteria:
Core Study
Mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia including
Impaired episodic memory confirmed by a list learning task
Positive biomarker for brain amyloid pathology as indicated by either amyloid positron emission tomography or cerebrospinal fluid AD assessment or both
Extension Phase
• Participants who complete the Core Study
Exclusion Criteria:
Core Study
Females who are breastfeeding or pregnant at Screening or Baseline. Females of child-bearing potential must use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation
Any condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
Participants with a history of seizures within 5 years of Screening
History of transient ischemic attacks or stroke within 12 months of Screening
Psychiatric diagnosis or symptoms (example, hallucinations, major depression, delusions etc.)
Suicidal ideation or any suicidal behavior within 6 months before Screening or has been hospitalized or treated for suicidal behavior in the past 5 years
Have any contraindications to magnetic resonance imaging (MRI) scanning or
Participants who have a history of moderate to severe hepatic impairment (example, Child-Pugh Class B or C)
Results of laboratory tests conducted during Screening that are outside the following limits:
Participants at increased risk of infection
Have received any live vaccine/live attenuated vaccine in the 3 months before randomization
Any chronic inflammatory disease that is not adequately controlled or that requires systemic immunosuppressive or immunomodulatory therapy
Any other clinically significant abnormalities
Severe visual or hearing impairment
A prolonged corrected QT (QTc) interval (QT interval with Fridericia's correction [QTcF] greater than 450 milliseconds [ms])
Malignant neoplasms within 5 years of Screening
Known or suspected history of drug or alcohol abuse
Taking prohibited medications, which must be reviewed with the Investigator
Have participated in a recent clinical study
Note: Other protocol-defined Inclusion/Exclusion Criteria may apply.
Caba, Buenos Aires -1405, Argentina
Caba, Buenos Aires C1012AAR, Argentina
Caba, Buenos Aires C1126AAB, Argentina
Caba, Buenos Aires C1427, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1111, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires 1430, Argentina
Ciudad Autonoma de Buenos Aires, Buenos Aires C1230AAZ, Argentina
Caba, C1428AQK, Argentina
Homburg/Saar, 66241, Germany
Anjo-shi, Aichi-ken 446-8510, Japan
Obu-shi, Aichi-ken 474-8511, Japan
Yoshida-gun, Fukui 910-1193, Japan
Kitakyushu-shi, Fukuoka 808-0024, Japan
Omuta-shi, Fukuoka 837-0911, Japan
Fujioka-shi, Gunma 375-0017, Japan
Otake-shi, Hiroshima 739-0651, Japan
Himeji-shi, Hyōgo 670-0981, Japan
Fujisawa-shi, Kanagawa 251-0038, Japan
Shimogyo-ku, Kyoto 600-8558, Japan
Higashimorokatagun, Miyazaki 880-1111, Japan
Kurashiki-shi, Okayama-ken 710-0813, Japan
Kurashiki-shi, Okayama-ken 710-8692, Japan
Naniwa-Ku, Osaka 556-0017, Japan
Sakai-shi, Osaka 593-8301, Japan
Suita-shi, Osaka 565-0871, Japan
Suita-shi, Osaka 565-0874, Japan
Suminoe-ku, Osaka 559-0004, Japan
Kanzaki-gun, Saga-ken 842-0192, Japan
Bunkyo-ku, Tokyo 113-0034, Japan
Bunkyo-ku, Tokyo 113-8603, Japan
Kodaira-shi, Tokyo 187-8551, Japan
Minato-ku, Tokyo 108-0073, Japan
Setagaya-ku, Tokyo 158-8531, Japan
Shinjuku-ku, Tokyo 169-0073, Japan
Sumida-ku, Tokyo 130-0004, Japan
Hofu-shi, Yamaguchi 747-0802, Japan
Poznari, 61-853, Poland
Winwick, Warrington, Cheshire WA2 8WA, United Kingdom