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Monoclonal Antibodies

Double-blind Treatment (DBT) Period: ACU193 35 mg/kg for Alzheimer's Disease (ALTITUDE-AD Trial)

Phase 2 & 3
Recruiting
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
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
Body weight of at least 30 kilograms (kg) (66 pounds [lbs]) and no more than 160 kg (352 lbs) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 80 weeks
Awards & highlights

ALTITUDE-AD Trial Summary

This trial aims to test if ACU193 infusions given every four weeks can help slow down mental and physical decline in people with early Alzheimer's disease compared to a placebo.

Who is the study for?
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.Check my eligibility
What is being tested?
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).See study design
What are the potential side effects?
Potential side effects of ACU193 are not detailed here, but common infusion-related reactions may include discomfort at the injection site, fever, chills, nausea, headache or allergic reactions.

ALTITUDE-AD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 66 and 352 lbs.

ALTITUDE-AD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 80 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 80 weeks 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 from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score
Secondary outcome measures
CSF Concentrations of ACU193 in a Subset of Participants
Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids
Change from Baseline in ADAS-Cog13 Score
+29 more

ALTITUDE-AD Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open-Label Extension (OLE) Period: ACU193 35 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 mg/kg, Q4W as an IV infusion during the OLE period.
Group II: Double-blind Treatment (DBT) Period: ACU193 35 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 milligrams per kilogram (mg/kg), Q4W as intravenous (IV) infusion during the DBT period.
Group III: DBT Period: ACU193 50 mg/kgExperimental Treatment1 Intervention
Participants will receive ACU193, 35 mg/kg, for the first two doses, followed by AUC193, 50 mg/kg, Q4W as an IV infusion during the DBT period.
Group IV: DBT Period: PlaceboPlacebo Group1 Intervention
Participants will receive AUC193 matching placebo, Q4W as an IV infusion during the DBT period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACU193
2021
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

Acumen PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
65 Total Patients Enrolled
Eric Siemers, MDPrincipal InvestigatorAcumen Pharmaceuticals
2 Previous Clinical Trials
115 Total Patients Enrolled

Frequently Asked Questions

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

What is the current enrollment size of participants for this research?

"For the successful completion of this research, a total of 2040 eligible individuals are needed. Acumen Pharmaceuticals, the trial sponsor, will oversee operations at various locations such as Hôpital de la Timone in Marseille Cedex 05 and Institut de la Mémoire et de la Maladie d'Alzheimer - IM2A in Paris, Lanarkshire."

Answered by AI

In how many medical facilities is this examination being conducted?

"The trial is being conducted at Hôpital de la Timone in Marseille Cedex 05, California; Institut de la Mémoire et de la Maladie d'Alzheimer - IM2A in Paris, Lanarkshire; and K2 Medical Research - Villages in Lady Lake, Barcelona. Additionally, there are another 126 sites involved in this study."

Answered by AI

Does this study include individuals who are older than 70 years?

"Individuals aged between 50 and 90 are eligible for enrollment in this study. It is noteworthy that there are 14 trials catering to those under 18 years old and a substantial number of 535 trials focusing on individuals older than 65."

Answered by AI

Are potential participants currently able to apply for enrollment in this study?

"Indeed, information on clinicaltrials.gov affirms the ongoing recruitment status of this investigation. Originally listed on February 29th, 2024, and last revised on March 21st, 2024, the study aims to enroll a substantial cohort of 2040 participants across an extensive network of 126 institutions."

Answered by AI

Who else is applying?

What site did they apply to?
Las Vegas Medical Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~1360 spots leftby Jan 2031