APOLLOE4

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects with Early Alzheimer's Disease and APOE4/4 Genotype

• IRAS ID

  295043

• Contact name

  Josephine MacSweeney

• Contact email

  EMacsweeney@re-cognitionhealth.com

• Sponsor organisation

  Alzheon, Inc.

• Eudract number

  2020-005755-20

• Clinicaltrials.gov Identifier

  NCT04770220

• Clinicaltrials.gov Identifier

  125760, IND

• Duration of Study in the UK

  3 years, 7 months, 1 days

• Research summary

  The purpose of this study is to determine if the study medicine called ALZ-801 is safe, well tolerated and effective in treating patients with early stage Alzheimer’s disease (AD) with a specific genotype (APOE4/4). Part of their diagnosis will be confirmed either by recently completed pre-screening testing related to this research study, or by previous testing done as part of another study or their regular care.

  Participants will be randomly assigned (by chance, like flipping a coin) to receive either ALZ-801 or placebo. They will have an equal (50% or 1 in 2) chance of being in the ALZ-801 group or in the placebo group. This is a double-blind study, which means neither the participant nor the study team will know which group the participant is assigned.
  Participant will take the study drug (ALZ-801 265mg or placebo) twice a day with a morning and an evening meal (or within 30 minutes after each full meal) with approximately 10-12 hours between doses.

  The placebo group will receive placebo throughout the study. The ALZ-801 group, for the first two weeks their total daily dose will be 265mg of ALZ-801 (only one of the tablets will contain active drug); after that their total daily dose for the rest of the study will increase to 530mg daily (both tablets will contain active drug). There is also an optional cerebrospinal fluid (CSF) sub-study.

  There will be up to 11 visits (including a possible pre-screening visit) at the site and 2 phone visits and will last up to 93 weeks. About 300 people are expected to participate in this study in North America and Europe. Participants will have a caregiver or study partner who will attend all visits with them.
  

• REC name

  Wales REC 5

• REC reference

  21/WA/0121

• Date of REC Opinion

  4 May 2021

• REC opinion

  Further Information Favourable Opinion