NCT04931459: INTERCEPT-AD

A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD

Completed Phase 1 Last updated 19 July 2023

What this trial tests

Phase 1 trial testing ACU193 in Alzheimer Disease in 65 participants. Completed in 12 June 2023.

Timeline

21 June 2021

Primary endpoint
12 June 2023

12 June 2023

Quick facts

Lead sponsor	Acumen Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	65
Start date	21 June 2021
Primary completion	12 June 2023
Estimated completion	12 June 2023
Sites	17 locations across United States

Drugs / interventions tested

• ACU193 — full drug profile →
• Placebo

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Acumen Pharmaceuticals — full company profile →

Who can join

Adults 55 to 90, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This Phase 1 study is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's disease (AD).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amyloid β-based therapy for Alzheimer's disease: challenges, successes and future.
   Zhang Y, Chen H, Li R, Sterling K, et al · · 2023 · cited 579× · PMID 37386015 · DOI 10.1038/s41392-023-01484-7
2. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
3. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
4. Second-generation anti-amyloid monoclonal antibodies for Alzheimer's disease: current landscape and future perspectives.
   Kim BH, Kim S, Nam Y, Park YH, et al · · 2025 · cited 55× · PMID 39865265 · DOI 10.1186/s40035-025-00465-w
5. Current Anti-Amyloid-β Therapy for Alzheimer's Disease Treatment: From Clinical Research to Nanomedicine.
   Zhao Z, Liu Y, Ruan S, Hu Y. · · 2023 · cited 31× · PMID 38144511 · DOI 10.2147/ijn.s444115
6. Gut Microbiota and Immunotherapy for Alzheimer's Disease.
   Dai CL, Liu F, Iqbal K, Gong CX. · · 2022 · cited 13× · PMID 36499564 · DOI 10.3390/ijms232315230
7. Trajectory of brain-derived amyloid beta in Alzheimer's disease: where is it coming from and where is it going?
   Liu N, Haziyihan A, Zhao W, Chen Y, et al · · 2024 · cited 12× · PMID 39160618 · DOI 10.1186/s40035-024-00434-9
8. Alzheimer's Disease and Frontotemporal Dementia: A Review of Pathophysiology and Therapeutic Approaches.
   Kelliny S, Zhou XF, Bobrovskaya L. · · 2025 · cited 9× · PMID 40387258 · DOI 10.1002/jnr.70046