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

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501644-15-00

Acronym

247AD201

Enrollment

327

Registered

2023-02-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-20

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

DRUGNeuraceq 300 MBq/mL solution for injection

DRUGBIIB080

DRUGMK-6240

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