Active — Not RecruitingPhase 2

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

United States542 participantsStarted 2024-02-29

Plain-language summary

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.

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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

Exclusion 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

What they're measuring

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Timeframe: Baseline up to Week 80

Trial details

NCT IDNCT06335173

SponsorAcumen Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Alzheimer Disease trials