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Alzheimer DiseasePhase 1INTERCEPT-ADNCT04931459

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

A Phase 1 study testing ACU193 in people with Alzheimer Disease, run by Acumen Pharmaceuticals at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer Disease
What is being tested?
ACU193
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
65 participants
Where
17 sitesUnited States
Study dates
21 Jun 2021to 12 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females ages 55 to 90 (inclusive).
  • Participant weighs at least 41 kg (90 lbs) and no more than 113 kg (250 lbs) before study drug administration.
  • Female participants must be surgically sterile or be at least two years post-menopausal or at least one year post-menopausal with an elevated follicle stimulating hormone (FSH). Male participants with a female partner of child-bearing potential must use adequate contraception.
  • Individual (or the participant's Legally Authorized Representative [LAR]) is able to give informed consent.
  • Are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Must meet all of the following clinical criteria for MCI due to AD or mild AD at Screening:
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  • Participant meets NIA-Alzheimer's Association (NIA-AA) criteria for MCI due to AD or probable AD.
  • A global Clinical Dementia Rating (CDR) of 0.5 or 1.0.
  • A Mini-Mental State Examination (MMSE) score between 18 and 30 (inclusive).
  • A positive amyloid positron emission tomography (PET) scan.
  • Must consent to apolipoprotein E (APOE) genotyping.
  • If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least four weeks prior to Baseline and the participant must be willing to keep the doses stable throughout the duration of the study.
  • Must have a reliable informant or caregiver who is willing and able to perform all caregiver roles as specified in the caregiver Informed Consent Form (ICF).

Who cannot join

  • Receipt of any investigational biological drug within less than one year of Baseline or of any investigational small molecule drug within less than six months of Baseline. Receipt of any approved treatments that target amyloid plaques in the brain within less than one year of Baseline.
  • Currently receiving or likely to require the following types of anticoagulants: coumarins and indandiones, Factor Xa inhibitors, heparins, thrombin inhibitors.
  • Has known humanized monoclonal antibody allergy or hypersensitivity.
  • History of significant neurological disease, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or adult epilepsy.
  • Has had magnetic resonance imaging (MRI) or computerized tomography (CT) of brain within previous two years showing pathology that would be inconsistent with a diagnosis of AD.
  • Has MRI with results showing greater than four amyloid-related imaging abnormalities hemorrhage/hemosiderin deposition (ARIA-H), presence of any amyloid-related imaging abnormalities edema/effusions (ARIA-E), or superficial siderosis.
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  • Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
  • Current serious or unstable clinically important illness that, in the judgment of the Investigator, is likely to affect cognitive assessment including visual and hearing impairment, deteriorate, or affect the participant's safety or ability to complete the study, including psychiatric, hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinological, immunologic, or hematologic disorders.
  • Has an ongoing or new clinically significant laboratory abnormality, as determined by the Investigator.
  • Has a history or presence of clinically significant abnormal 12-lead electrocardiogram (ECG) or an ECG with QT interval corrected using Fridericia's formula (QTcF) >470 msec for female participants or >450 msec for male participants. As the ECGs are obtained in triplicate and are meant to be interpreted together, if one of the three ECGs in the triplicate has a QTcF above the threshold, eligibility of the participant should be determined based on clinical judgment of the Investigator in consultation with the medical monitor. If two of the three ECGs in the triplicate have a QTcF above the threshold, then the participant would not be eligible.
  • Within one year before Screening, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia.
  • History of seizure, transient ischemic attack (TIA), or stroke within the last 18 months.
  • History of clinically significant carotid or vertebrobasilar stenosis or plaque.
  • History of a malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment within the last five years.
  • Current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the Investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study.
  • Are a suicide risk, as determined by meeting any of the following criteria:
  • Suicide attempt within the six months prior to Baseline.
  • Suicidal ideation as defined by a positive response to Question 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation section.
  • Significant risk of suicide, as judged by the site Investigator.
  • History of multiple concussions, significant head trauma, or objective change in neuropsychological function within the last five years.
  • History of human immunodeficiency virus (HIV).
  • History of alcohol or drug abuse/dependence within the last five years.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19001

  • Orange County Research Institute

    Anaheim, California, 92801

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Kerwin Medical Center

    Dallas, Texas, 75231

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • Velocity Clinical Research

    Hallandale, Florida, 33009

  • Clinical Trials Network

    Houston, Texas, 77074

  • Charter Research

    Lady Lake, Florida, 32159

  • AMC Research

    Matthews, North Carolina, 28105

  • Columbus Clinical Services

    Miami, Florida, 33125

  • Columbia University

    New York, New York, 10032

  • Hoag Hospital Newport Beach

    Newport Beach, California, 92663

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Progressive Medical Research

    Port Orange, Florida, 32321

  • Clinical Endpoints

    Scottsdale, Arizona, 85258

  • Santos Research Center

    Tampa, Florida, 33615

  • Advanced Memory Research Institute of NJ

    Toms River, New Jersey, 08755

Other trials in United States

About this study

Official title: A Phase 1 Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous ACU193 in Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

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).

Being tested
ACU193, Placebo
Keywords
Alzheimer's Diseases, Mild Cognitive Impairment, Mild dementia
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACU193Drug

    Intravenous ACU193

  • PlaceboDrug

    Intravenous Placebo

Study groups in NCT04931459
Study groupRoleWhat they receive
ACU193 AdministrationExperimentalParticipants will receive 1 to 3 doses of ACU193 by intravenous (IV) infusion.
Receives: Drug: ACU193
Placebo AdministrationPlacebo comparatorParticipants receive 1 to 3 doses of matching ACU193 placebo by intravenous (IV) infusion. 2 participants per cohort will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and Nature of Treatment-Related Adverse Events (AE) or Serious Adverse Events (SAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

    Proportion of participants with AE, discontinuations due to AE or SAE, and withdrawals from the study due to AE

    Measured: Baseline up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)

  2. Change in Clinical Laboratory Tests

    Incidence and clinically significant abnormal changes in clinical laboratory assessments (hematology, clinical chemistry, urinalysis)

    Measured: Baseline up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)

  3. Changes in 12-Lead ECGs

    Clinically significant abnormal changes in 12-Lead ECGs for PR, QRS, QT, QTcF, and QTcB

    Measured: Baseline up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)

  4. Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Presence of suicidal ideation as defined by a positive response to Question 5 on the C-SSRS suicide ideation section

    Measured: Baseline up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)

  5. Changes in Magnetic Resonance Imaging (MRI)

    Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)

    Measured: Baseline (predose) up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)

Secondary outcomes (6)

  1. Estimate Blood Levels of ACU193

    Area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt)

    Measured: Up to 140 days post dose

  2. Estimate Maximum Blood Levels of ACU193

    Maximum observed blood concentration Cmax(obs).

    Measured: Up to 140 days post dose.

  3. Estimate Time to Reach Maximum Blood Levels of ACU193

    Time to reach Tmax(obs)

    Measured: Up to 140 days post dose.

  4. Estimate Blood Levels of ACU193

    Area under the plasma concentration-time curve from time 0 to infinity (AUC∞)

    Measured: Up to 140 days post dose.

  5. Estimate Clearance of ACU193

    Clearance (CL)

    Measured: Up to 140 days post dose

  6. Estimate Volume of Distribution of ACU193

    Apparent volume of distribution at terminal phase (Vz)

    Measured: Up to 140 days post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start21 Jun 2021
  3. Primary completion12 Jun 2023
  4. Study completion12 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study ACU-001 is a placebo-controlled study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple escalating doses of intravenous ACU193. A two-part single-ascending dose (SAD)/multiple-ascending dose (MAD) study design will be conducted in a population of individuals with early AD (MCI or mild dementia due to AD).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04931459
Sponsor's protocol ID
ACU-001
Other IDs
3U01AG053247
Acronym
INTERCEPT-AD
Status last verified
Jul 2023
First submitted
18 May 2021
Last updated
19 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ACU193 in people with Alzheimer Disease, run by Acumen Pharmaceuticals at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and Nature of Treatment-Related Adverse Events (AE) or Serious Adverse Events (SAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) (time frame: Baseline up to 20 weeks (SAD); 14, 18 or 28 weeks (MAD)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04931459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.

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