A Phase 3 Double-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508306-15-00

Acronym

AR1001-ADP3-US01

Enrollment

456

Registered

2024-04-22

Start date

2024-06-26

Completion date

Unknown

Last updated

2026-01-22

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

Conditions

Alzheimer’s Disease

Brief summary

1. Change in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) from Baseline to Week 52

Detailed description

1. Change in the Alzheimer’s Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13) from Baseline to Week 52, 2. Change in the Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) from Baseline to Week 52, 3. Change in the Geriatric Depression Scale-15 (GDS-15) from Baseline to Week 52, 4. Change in the Mini-Mental Status Examination (MMSE) from Baseline to Week 52

Interventions

DRUGAR1001

DRUGPlacebo tablet

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Change in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) from Baseline to Week 52	—

Secondary

Measure	Time frame
1. Change in the Alzheimer’s Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13) from Baseline to Week 52, 2. Change in the Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV) from Baseline to Week 52, 3. Change in the Geriatric Depression Scale-15 (GDS-15) from Baseline to Week 52, 4. Change in the Mini-Mental Status Examination (MMSE) from Baseline to Week 52	—

Measure

Time frame

—

Countries

Czechia, Denmark, France, Germany, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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