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Anti-amyloid agent
AGB101 for Mild Cognitive Impairment
Baltimore, MD (>99 mi)
Phase 2
Recruiting
Research Sponsored by AgeneBio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 78 weeks
Summary
This trial aims to test if AGB101 can help slow down memory loss and functional decline in individuals with mild cognitive impairment due to Alzheimer's Disease. Participants will either receive a placebo or AGB101
See full description
Who is the study for?
This trial is for individuals with mild cognitive impairment due to Alzheimer's, who can consent and participate for 78 weeks. They should have at least an eighth-grade education or equivalent work history, adequate sensory abilities for testing, a study partner to assist them, MMSE scores of 24-30, and a specific memory complaint.
What is being tested?
The trial tests AGB101 (220 mg daily) against a placebo to see if it slows down cognitive decline in Alzheimer's patients over 78 weeks. It measures the reduction in neuronal injury and assesses clinical progression using dementia rating scales.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions typical of medications affecting brain function such as headaches, dizziness, gastrointestinal issues or changes in mood or behavior.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 78 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~78 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Entorhinal Cortex (EC) Volume From Baseline
Secondary study objectives
Change in Clinical Dementia Rating Scale - Memory Box Score From Baseline
Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score From Baseline
Side effects data
From 2023 Phase 4 trial • 82 Patients • NCT018010728%
Seizure
5%
Stroke
3%
Delirium
3%
Headache
3%
Patient received extra Keppra
3%
Unexplained Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
No Levetiracetam
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AGB101 220 mg tabletExperimental Treatment1 Intervention
Single 220 mg AGB101 tablet once daily, taken orally, for 78 weeks.
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Matching placebo to AGB101 tablet once daily, taken orally, for 78 weeks
Find a Location
Closest Location:Johns Hopkins· Baltimore, MD· 344 miles
Who is running the clinical trial?
AgeneBioLead Sponsor
2 Previous Clinical Trials
194 Total Patients Enrolled