Phase 2 Study of BIIB080 in Participants with MCI Due to AD or Mild AD Dementia

JRCT ID: jRCT2031220635

Registered date:12/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's Disease Dementia
• Date of first enrollment: 25/04/2023
• Target sample size: 735
• Countries of recruitment: USA,Japan,Canada,Japan,Denmark,Japan,Finland,Japan,Sweden,Japan,Poland,Japan,Germany,Japan,Czech Republic,Japan,Netherlands,Japan,Belgium,Japan,Switzerland,Japan,France,Japan,UK,Japan,Spain,Japan,Italy,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

Research Name: BIIB080 (previously known as ISIS
814907)
Generic Name: Not applicable

Participants will receive study treatment via IT injection every 12 weeks, starting on Study Day 1. Participants in BIIB080 60 mg Q24W and BIIB080 115 mg Q24W arms will receive BIIB080 at Weeks 1, 24, 48, and 72 and placebo at Weeks 12, 36, and 60. Participants in the Placebo arm will receive placebo at each dosing visit. Participant in the BIIB080 115 mg Q12W arm will receive BIIB080 115 mg at each dosing visit.

Outcome(s)

• Primary Outcome: Dose-response in change from Baseline to Week 76 on the CDR-SB

Secondary Outcome

- Change from Baseline to Week 76 on the CDR-SB

- Change from Baseline to Week 76 on the following:
- ADCS-ADL-MCI
- ADAS-Cog 13
- MMSE
- Modified iADRS
- ADCOMS

- Incidence of treatment-emergent AEs and SAEs

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Must meet all the clinical staging criteria for MCI due to AD (Stage 3) or mild AD dementia (Stage 4) according to the NIA-AA and must have the following at Screening Visit 1:
- RBANS Delayed Memory Index score of <= 85, indicative of objective evidence of memory impairment.
- CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD dementia.
- MMSE score of 22 to 30 (inclusive).
- CDR Memory Box score of >= 0.5.

2. Evidence of amyloid pathology as measured by PET or CSF sampling.

Exclude criteria

1. Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product .

2. Previous participation in this study or previous studies with BIIB080.

3. Use of non-disease-modifying AD medications (including but not limited to donepezil, rivastigmine, galantamine, and memantine) at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.

4. Prior participation in any active or passive immunotherapy study targeting amyloid beta, unless documentation of receipt of placebo is available.

5. Prior participation in any passive immunotherapy study targeting tau, unless the last administration occurred 6 months or 5 half-lives, whichever is sooner, prior to Screening or documentation of receipt of placebo is available.

6. Participation in any study involving an investigational treatment targeting tau that is not an immunotherapy, unless documentation of receipt of placebo is available.

7. Participation in a study of any other agent(s) [including gene therapy] not included in exclusion criteria 4, 5, and 6 with a purported disease-modifying effect in AD, unless documentation of receipt of placebo is available.

8. Current use or previous use of medications with a purported disease-modifying effect in AD, outside of investigational studies.

9. Any vaccination given within 10 days prior to Day -1. COVID-19 vaccinations using RNA or DNA technology are allowed during the study, as well as other types of immunization/vaccination/booster, except during the 10 days before and after clinic visits.

10. Contraindications to having a brain MRI (e.g., MRI-incompatible pacemaker; MRI incompatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed). If the MRI compatibility of implanted devices is unknown, the participant must be excluded from the study.

11. Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 52 weeks prior to the Baseline Visit.

Related Information

• Primary Sponsor: Toda Yasuo
• Secondary ID(s): NCT05399888