LTE of Phase 3 Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4-LTE) ALZ-801-AD351

• Research type

  Research Study

• Full title

  Long-term Extension of a Phase 3, Multicenter, Randomized, Double-Blind, PlaceboControlled Study of the Efficacy, Safety, and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer’s Disease and APOE4/4 Genotype

• IRAS ID

  1009596

• Contact name

  Aidan Power

• Contact email

  Aidan.power@alzheon.com

• Sponsor organisation

  Alzheon, Inc.

• Research summary

  This 52-week study (APOLLOE4-LTE) is an open-label long-term extension (LTE) of the 78-week, Phase 3, multicentre, randomised, double-blind, placebo controlled study (APOLLOE4, NCT04770220). Participants who complete Week 78 (Visit 11) of the core Phase 3, APOLLOE4 while on study drug and who are willing and eligible for APOLLOE4-LTE will be enrolled and receive the study medicine, ALZ-801.
  The purpose of this LTE study is to determine if the long-term use of ALZ-801, is safe, well tolerated (how the body reacts to the study medicine) and if it is effective in treating Alzheimer’s Disease (AD).

  APOLLOE4 enrolled male and female participants aged 50 to 80 years, who had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease, which included Mild Cognitive Impairment and Mild Dementia due to AD when they enrolled. Half of the participants received ALZ-801 and the other half received placebo (does not contain any active ingredients but looks identical to the ALZ-801 tablet). A placebo will not be used in the APOLLOE4-LTE study. This means that, even if participants were assigned to placebo in the APOLLOE4 study, participants will receive ALZ-801 if they decide to take part in this LTE study. Open label means all participants will get active drug in the LTE, but neither the participant nor the study team will know the previous study medicine assignment.
  Up to 285 eligible and willing participants will participate in APOLLOE4-LTE. All participants will receive the same treatment, ALZ-801 265 mg twice per day (BID) after a 4-week titration period. Participation in this LTE study will last up to 52 weeks. If participants join at the time, or, less than 12 weeks after APOLLOE4 Study Visit 11 they will join the “Rollover” group. I they join 12 weeks or longer after APOLLOE4 Study Visit 11 they will join the “Gap” group.

• REC name

  Wales REC 5

• REC reference

  24/WA/0083

• Date of REC Opinion

  8 Apr 2024

• REC opinion

  Further Information Favourable Opinion