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AGB101 220 mg tablet for Mild Cognitive Impairment (HOPE4MCI Trial)

Phase 2 & 3

Waitlist Available

Led By Richard Mohs, PhD

Research Sponsored by AgeneBio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have eighth-grade education or good work history sufficient to exclude mental retardation

Have visual and auditory acuity adequate for neuropsychological testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 78 weeks

Awards & highlights

HOPE4MCI Trial Summary

This trial is testing whether AGB101 can help slow cognitive and functional decline in people with mild Alzheimer's disease.

Eligible Conditions

Mild Cognitive Impairment
Alzheimer's Disease

HOPE4MCI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have a CDR score of 0.5 or a memory box score of ≥0.5.

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You have a memory complaint.

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You are able to understand and communicate in the local language.

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You have a minimum score of 24 on the Mini-Mental State Examination (MMSE).

HOPE4MCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 78 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~78 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 78 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

CDR-SB

Secondary outcome measures

FAQ

MMSE

HOPE4MCI 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AGB101 220 mg tablet

2018

Completed Phase 3

~170

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AgeneBioLead Sponsor

2 Previous Clinical Trials

1,070 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,662 Previous Clinical Trials

28,005,024 Total Patients Enrolled

Sharon Rosenzweig-Lipson, PhDStudy DirectorAgeneBio

Frequently Asked Questions

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

Does this research project allow for volunteers who are younger than 25 years old?

"This trial is recruiting patients that are between 55 and 85 years old."

Answered by AI

How many research centers are coordinating this clinical trial?

"There are 24 available for this clinical trial including NeuroStudies.net, LLC in Decatur, Clinical Biotechnology Research Institute at RSFH in Charleston, and Brain Matters Research in Delray Beach,as well as 21 other locations."

Answered by AI

To whom does this research project offer enrollment?

"This trial is looking for 164 participants aged 55-85 who have Alzheimer's disease. In addition to this, potential participants must: have a memory complaint reported by themselves or their study partner, have a CDR score of 0.5 with a memory box score of ≥0.5, have at least an eighth-grade education or good work history, have visual and auditory acuity adequate for neuropsychological testing, be proficient in the native local language, have a study partner who has sufficient contact with the subject and is able to accompany them to all clinic visits, and finally have an MMSE score between 24 and 30."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

2018. "Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03486938.