A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild Alzheimer’s Disease Dementia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501644-15-01

Acronym

247AD201

Enrollment

233

Registered

2023-08-14

Start date

2023-09-28

Completion date

Unknown

Last updated

2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment due to Alzheimer's Disease Alzheimer's Disease Dementia

Brief summary

Dose-response in change from Baseline to Week 76 on the CDR-SB

Detailed description

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, Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Interventions

DRUGBIIB080

DRUGNeuraceq 300 MBq/mL solution for injection

DRUGVIZAMYL 400 MBq/mL solution for injection

DRUGPlacebo for BIIB080: artificial cerebrospinal fluid diluent

DRUGsolution for injection.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Dose-response in change from Baseline to Week 76 on the CDR-SB	—

Secondary

Measure	Time frame
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, Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	—

Countries

Belgium, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026