ACU193 for Early Alzheimer's Disease

(ALTITUDE-AD Trial)

Recruiting at 128 trial locations

Overseen By Alyssa Carroll

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Acumen Pharmaceuticals

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The primary purpose of this study is to evaluate the efficacy of sabirnetug infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

Research Team

Eric Siemers, MD

Principal Investigator

Acumen Pharmaceuticals

Eric Siemers, MD

Principal Investigator

Acumen Pharmaceuticals

Eligibility Criteria

This trial is for individuals with early Alzheimer's Disease who can attend regular infusions every four weeks. Specific eligibility details are not provided, but typically participants must meet certain health criteria and agree to follow the study procedures.

Inclusion Criteria

My weight is between 66 and 352 lbs.

I agree to have my APOE4 gene status checked.

Must meet all of the following criteria: National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD, Screening and baseline score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE), Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score, Evidence of cerebral amyloid accumulation by either PET scan or CSF, If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study, Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF), Female participants must be surgically sterile or be at least one-year post-menopausal, Male participants with a female partner of child-bearing potential must use adequate contraception

Exclusion Criteria

Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI, MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis, History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease, Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study, Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA), Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site 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, Suicide risk, as determined by meeting any of the following criteria: Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months, Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening, Significant risk of suicide, as judged by the site investigator, Conditions that may affect cognitive assessments during the study, Alcohol use disorder and/or substance use disorder within the last five years

Treatment Details

Interventions

• ACU193 (Monoclonal Antibodies)

Trial Overview The trial is testing ACU193, a drug given through an IV once a month, to see if it slows down memory loss and daily functioning decline in people with early Alzheimer's compared to a placebo (a treatment with no active drug).

Participant Groups

Group I: Open-Label Extension (OLE) Period: sabirnetug 35 mg/kg Experimental Treatment 1 Intervention

Participants will receive sabirnetug, 35 mg/kg, Q4W as an IV infusion during the OLE period.

Group II: Double-blind Treatment (DBT) Period: sabirnetug 35 mg/kg Experimental Treatment 1 Intervention

Participants will receive sabirnetug, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.

Group III: DBT Period: sabirnetug 50 mg/kg Experimental Treatment 1 Intervention

Participants will receive sabirnetug, 35 mg/kg, for the first two doses, followed by sabirnetug, 50 mg/kg, Q4W as an IV infusion during the DBT period.

Group IV: DBT Period: Placebo Placebo Group 1 Intervention

Participants will receive sabirnetug matching placebo, Q4W as an IV infusion during the DBT period.

Who Is Running the Clinical Trial?

Acumen Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

630+