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A Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Intravenous Sabirnetug in Early Alzheimer’s Disease

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509807-34-00
Acronym
ACU193-201
Enrollment
175
Registered
2024-07-17
Start date
2024-08-12
Completion date
Unknown
Last updated
2026-01-21

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

Conditions

Early Alzheimer’s Disease (Mild Cognitive Impairment and Mild Dementia Due to Alzheimer’s Disease)

Brief summary

Change from Baseline to Week 80 in the iADRS score.

Detailed description

1. Change from Baseline to Week 80 in the ADCS-iADL, ADAS-Cog13, CDR-SB, and MMSE., 2. Change from Baseline to Week 80 in QoL-AD, 3. Further Secondary, Clinical, Safety, Pharmacodynamic, Pharmacokinetics, Pharmacogenomic, Blood and CSF Biomarker and Exploratory Endpoints are visible in the study protocol., 4. OLE: Changes from Baseline to Week 104 and Week 132 for iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE as measured by delayed-start analysis.

Interventions

Sponsors

Acumen Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline to Week 80 in the iADRS score.

Secondary

MeasureTime frame
1. Change from Baseline to Week 80 in the ADCS-iADL, ADAS-Cog13, CDR-SB, and MMSE., 2. Change from Baseline to Week 80 in QoL-AD, 3. Further Secondary, Clinical, Safety, Pharmacodynamic, Pharmacokinetics, Pharmacogenomic, Blood and CSF Biomarker and Exploratory Endpoints are visible in the study protocol., 4. OLE: Changes from Baseline to Week 104 and Week 132 for iADRS, CDR-SB, ADCS-iADL, ADAS-Cog13, and MMSE as measured by delayed-start analysis.

Countries

France, Germany, Spain

Outcome results

None listed

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