A Study to Evaluate the Safety, Tolerability, and Blood Levels of ACU193 in Participants With MCI or Mild AD (INTERCEPT-AD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04931459|
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : October 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: ACU193 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||June 21, 2021|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||June 2023|
Experimental: ACU193 Administration
Participants will receive 1 to 3 doses of ACU193 by intravenous (IV) infusion.
Placebo Comparator: Placebo Administration
Participants receive 1 to 3 doses of matching ACU193 placebo by intravenous (IV) infusion.
2 participants per cohort will receive placebo.
- 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); 24 or 28 weeks (MAD) ]Proportion of participants with AE, discontinuations due to AE or SAE, and withdrawals from the study due to AE
- Change in Clinical Laboratory Tests [ Time Frame: Baseline up to 20 weeks (SAD); 24 or 28 weeks (MAD) ]Incidence and clinically significant abnormal changes in clinical laboratory assessments (hematology, clinical chemistry, urinalysis)
- Changes in 12-Lead ECGs [ Time Frame: Baseline up to 20 weeks (SAD); 24 or 28 weeks (MAD) ]Clinically significant abnormal changes in 12-Lead ECGs for PR, QRS, QT, QTcF, and QTcB
- Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline up to 20 weeks (SAD); 24 or 28 weeks (MAD) ]Presence of suicidal ideation as defined by a positive response to Question 5 on the C-SSRS suicide ideation section
- Changes in Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline (predose) up to 20 weeks (SAD); 24 or 28 weeks (MAD) ]Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
- Estimate Blood Levels of ACU193 [ Time Frame: Up to 140 days post dose ]Area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt)
- Estimate Maximum Blood Levels of ACU193 [ Time Frame: Up to 140 days post dose. ]Maximum observed blood concentration Cmax(obs).
- Estimate Time to Reach Maximum Blood Levels of ACU193 [ Time Frame: Up to 140 days post dose. ]Time to reach Tmax(obs)
- Estimate Blood Levels of ACU193 [ Time Frame: Up to 140 days post dose. ]Area under the plasma concentration-time curve from time 0 to infinity (AUC∞)
- Estimate Clearance of ACU193 [ Time Frame: Up to 140 days post dose ]Clearance (CL)
- Estimate Volume of Distribution of ACU193 [ Time Frame: Up to 140 days post dose ]Apparent volume of distribution at terminal phase (Vz)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931459
|Contact: Clinical Trialsfirstname.lastname@example.org|
|Principal Investigator:||Eric Siemers, MD||Acumen Pharmaceuticals, Inc.|
|Study Director:||Russell Barton||Acumen Pharmaceuticals, Inc.|
|Study Director:||Alyssa Carroll||Acumen Pharmaceuticals, Inc.|