Group A - Active Comparator for Early-Onset Alzheimer's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Brainstorm Research, Miami, FLEarly-Onset Alzheimer's Disease+1 MoreAR1001 - Drug
Eligibility
55 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new drug to treat early Alzheimer's. It's a carefully designed, safe study to see if it works.

Eligible Conditions
  • Early-Onset Alzheimer's Disease
  • Alzheimer's Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: 160 weeks

156 weeks
Biomarker Analysis
Exploratory Analysis
Safety Analysis
160 weeks
Changes of C-SSRS (Columbia Suicide Severity Rating Scale).
Exploratory - To evaluate the efficacy of AR1001 in the extension study
Treatment Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
52 weeks
ADAS-Cog 13
ADL Scale (ADCS-ADL)
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13)
Amsterdam-Cognitive Composite (A-CC)
Amsterdam-Cognitive and Functional Composite (A-CFC)
Amsterdam-IADL short version (A-IADL)
Amsterdam-IADL short version (A-IADL-SV)
Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV)
Change in cerebral spinal fluid (CSF) and/or plasma p-tau181
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Estimands
Exploratory - To evaluate AD related biomarkers
Geriatric Depression Scale (GDS)
Integrated Alzheimer's Disease Rate Scale
Mini-Mental Status Examination (MMSE)
Quality of Life in Alzheimer's Disease (QOL-AD)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
The Rey-Osterrieth Complex Figure Test (RCFT)
To evaluate the efficacy of AR1001 compared to Placebo in participants with Early Alzheimer's disease

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

Group A - Active Comparator
1 of 2
Group B - Placebo Comparator
1 of 2

Active Control

Non-Treatment Group

800 Total Participants · 2 Treatment Groups

Primary Treatment: Group A - Active Comparator · Has Placebo Group · Phase 3

Group A - Active Comparator
Drug
ActiveComparator Group · 1 Intervention: AR1001 · Intervention Types: Drug
Group B - Placebo Comparator
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 160 weeks

Who is running the clinical trial?

AriBio Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
210 Total Patients Enrolled
Fred KimStudy DirectorAriBio USA, Inc.
James RockStudy DirectorCEO
3 Previous Clinical Trials
1,042 Total Patients Enrolled

Eligibility Criteria

Age 55 - 80 · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

Is participation in this experiment open to individuals over forty years of age?

"The age requirements for this clinical trial are between 55 and 80 years old, as per the guidelines outlined in the inclusion criteria." - Anonymous Online Contributor

Unverified Answer

Who would be a suitable candidate to enroll in this clinical research project?

"To be admitted to this clinical trial, potential enrollees must have been diagnosed with Alzheimer's disease and are between the ages of 55-80. Approximately 800 people will need to participate in order for the results to be valid." - Anonymous Online Contributor

Unverified Answer

What potential hazards exist for individuals taking Group A - Active Comparator?

"Our experts at Power have rated Group A - Active Comparator's safety as a 3 due to the abundance of clinical evidence indicating efficacy and multiple instances validating its security." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor currently seeking participants?

"Affirmative. The clinicaltrials.gov database shows that this investigation is recruiting participants, having been first posted on December 1st 2022 and most recently updated on the 19th of December 2022. It aims to recruit 800 patients from one location." - Anonymous Online Contributor

Unverified Answer

How many individuals have been accepted for this clinical trial thus far?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently in the process of recruitment and was initially published on December 1st 2022 with its most recent updates being posted on December 19th 2022. 800 candidates are needed for participation from one site." - Anonymous Online Contributor

Unverified Answer

What is the aim of this research endeavor?

"This research project will evaluate the primary outcome, Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB), for a period of 1 year. Secondary endpoints include alterations in Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13); Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADLQSV); and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.