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ACU193 for Alzheimer's Disease (INTERCEPT-AD Trial)

Phase 1
Waitlist Available
Led By Eric Siemers, MD
Research Sponsored by Acumen Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 45 days
Treatment Varies
Follow Up baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad)
Awards & highlights

INTERCEPT-AD Trial Summary

This trial is testing a new drug for safety, side effects, and how it works in people with early Alzheimer's disease.

INTERCEPT-AD Trial Timeline

Screening ~ 45 days
Treatment ~ Varies
Follow Up ~baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad)
This trial's timeline: 45 days for screening, Varies for treatment, and baseline up to 20 weeks (sad); 14, 18 or 28 weeks (mad) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Clinical Laboratory Tests
Changes in 12-Lead ECGs
Changes in Magnetic Resonance Imaging (MRI)
+2 more
Secondary outcome measures
Estimate Blood Levels of ACU193
Estimate Clearance of ACU193
Estimate Maximum Blood Levels of ACU193
+2 more

INTERCEPT-AD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ACU193 AdministrationExperimental Treatment1 Intervention
Participants will receive 1 to 3 doses of ACU193 by intravenous (IV) infusion.
Group II: Placebo AdministrationPlacebo Group1 Intervention
Participants receive 1 to 3 doses of matching ACU193 placebo by intravenous (IV) infusion. 2 participants per cohort will receive placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACU193
2021
Completed Phase 1
~70

Find a Location

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,998 Total Patients Enrolled
Acumen PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
2,040 Total Patients Enrolled
James Senetar, PharmDStudy DirectorAcumen Pharmaceuticals, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently accept new enrollees?

"As of this moment, clinicaltrials.gov indicates that recruitment for the trial is ongoing. This medical study was initially publicized on June 21st 2021 and has been regularly updated since then, with its most recent amendment occurring October 28th 2022."

Answered by AI

How many volunteers have enrolled in this research endeavor?

"This medical study demands 62 participants that match the qualifications for inclusion. Two of the sites offering this trial are Neuro-Behavioral Clinical Research, Inc. in North Canton, Ohio and Atlanta Center for Medical Research in Atlanta, Georgia."

Answered by AI

Does this trial call for participants who are older than forty-five?

"The research team is seeking out individuals aged between 55 and 90 who meet the criteria for this clinical trial."

Answered by AI

To which patient demographic is this clinical trial open?

"This experiment is admitting 62 individuals suffering from Alzheimer's between the ages of 55 and 90. To qualify, candidates must fulfill a multitude of criteria including having an MMSE score between 18 to 30 (inclusive), a CDR rating of 0.5 or 1.0, weigh at least 41kg (90lbs) but no more than 113 kg (250 lbs). Additionally, they need to be willing and able to comply with scheduled visits as well as consenting to APOE genotyping if female participants are not surgically sterile; they must also be post-menopausal for one year with elevated FSH levels or two years without"

Answered by AI

What is the chief aim of this clinical exploration?

"The primary outcome of this medical trial, which will be tracked from Baseline up to 20 weeks for SAD and 24 or 28 weeks for MADs is a change in clinical laboratory tests. Secondary objectives include estimating the area under the plasma concentration-time curve (AUC∞), volume at terminal phase (Vz) and time to reach peak blood levels (Tmax(obs))."

Answered by AI

What precautions should be taken when administering ACU193 to patients?

"Considering the limited data on ACU193's efficacy and safety, it was rated a 1."

Answered by AI

How many locations are actively participating in this experiment?

"Neuro-Behavioral Clinical Research, Inc. in North Canton, Ohio, Atlanta Center for Medical Research in Atlanta, Georgia and Orange County Research Institute in Anaheim, California are 3 of the 19 medical sites running this trial."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Georgia
New York
Other
How old are they?
18 - 65
What site did they apply to?
Clinical Endpoints
iResearch Atlanta
Abington Neurological Associates
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
2

What questions have other patients asked about this trial?

How soon will trial start? When will I be notified of my acceptance? Neither I nor my caretaker/husband drive. Can you provide Uber to the testing site?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I am currently taking Memanzine a. I’d like to slow the progression of Alz symptoms if possible.
PatientReceived 2+ prior treatments
Have recently finished a trial drug with Advanced Research. So far, no success.
PatientReceived no prior treatments
I’m on multiple drugs and hoping for something that will slow progression of my Alzheimer.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Phone Call
Most responsive sites:
  1. Columbia University: < 24 hours
  2. iResearch Atlanta: < 48 hours
  3. Clinical Endpoints: < 48 hours
Average response time
  • < 2 Days
~17 spots leftby Apr 2025