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AR1001 for Alzheimer's Disease
Verified Trial
Phase 3
Recruiting
Research Sponsored by AriBio Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female participants aged 55 to 90 years of age inclusive at the time of signing the informed consent form
Mild cognitive impairment or mild dementia consistent with AD defined by stages 3 to 4 according to the National Institute on Aging and Alzheimer's Association (NIA-AA) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 156 weeks
Awards & highlights
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.
Who is the study for?
Adults aged 55-90 with early Alzheimer's Disease (AD), confirmed by specific cognitive tests and biomarkers, can join this trial. They need a reliable caregiver to assist and must not have other dementia causes or severe health issues like recent heart problems, uncontrolled seizures, or certain infections.Check my eligibility
What is being tested?
The study is testing AR1001 against a placebo in people with early AD. It's a Phase 3 trial where participants are randomly assigned to either the new drug or an inactive substance without knowing which one they receive.See study design
What are the potential side effects?
While the side effects of AR1001 aren't specified here, similar drugs may cause gastrointestinal issues, confusion, dizziness, headaches, and allergic reactions. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 90 years old.
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I have mild memory loss or mild dementia due to Alzheimer's disease.
Select...
You have experienced memory and thinking problems in the last 5 years, confirmed by a study partner.
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My MRI ruled out other causes for my dementia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 156 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~156 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)
Secondary outcome measures
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-Cog 13)
Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV)
Geriatric Depression Scale (GDS)
+1 moreOther outcome measures
Biomarker Analysis
Exploratory Analysis
Safety Analysis
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group A - Active ComparatorActive Control1 Intervention
Active, AR1001 30 mg QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 104 weeks.
Group II: Group B - Placebo ComparatorPlacebo Group1 Intervention
Placebo QD will be administered daily for 52 weeks during the Treatment Phase of the study. In the Extension Phase, all eligible participants who choose to participate will receive AR1001 30 mg QD for 104 weeks.
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Who is running the clinical trial?
AriBio Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
210 Total Patients Enrolled
Fred KimStudy DirectorAriBio Co., Ltd.
James RockStudy DirectorCEO
3 Previous Clinical Trials
1,042 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer or a malignant tumor in the last 5 years, except for certain types.I am not taking, or can stop taking, drugs that strongly affect liver enzyme CYP3A4 for 2 weeks.The doctor thinks that you might be at risk of hurting yourself.My MRI ruled out other causes for my dementia.You have had problems with alcohol or drugs in the last 5 years, according to the DSM-5 guidelines.I have a history of Hepatitis C or tested positive for it, but a PCR test confirmed I'm currently negative.You have a history of neurosyphilis or tested positive for RPR during screening.I have mild memory loss or mild dementia due to Alzheimer's disease.I am not on strong blood thinners or have conditions that make a spinal tap unsafe.You have other neurological conditions that might affect the study evaluations.You tested positive for the Hepatitis B surface antigen (HBsAg).You have a current psychiatric diagnosis that could make it hard to understand the effects of the drug, affect thinking tests, or make it difficult to finish the study.You have a certain level of disability as determined by a rating scale.Your score on a memory test is 85 or lower.You have had specific tests for markers related to Alzheimer's disease, and the results show certain levels that are not within normal ranges.I have had serious heart issues like a heart attack or heart failure in the last year.I had skin cancer or cervical dysplasia, but it's been treated.My blood pressure is not within the normal range despite retesting.My liver tests are more than 2.5 times the normal limit, but I don't have Gilbert's syndrome.I have an inherited eye condition that affects my retina.My prostate cancer is under control with stable PSA levels for 2 years.I have been on a stable dose of medication for Alzheimer's for at least 3 months.I had early-stage cervical cancer treated over 2 years ago with no recurrence.I do not have an uncontrolled seizure disorder affecting my thinking.I am currently or have been treated for Alzheimer's with specific therapies.You have experienced memory and thinking problems in the last 5 years, confirmed by a study partner.You have a score of 20 or higher on the Mini-Mental State Examination (MMSE).I do not have any cognitive issues unrelated to Alzheimer's disease.I am not on any medications that the study does not allow.Your GDS-15 score is 8 or higher during screening.You have been diagnosed with vascular dementia in the past.Your vitamin B12 levels are too low.I am between 55 and 90 years old.I am a woman who is pregnant, nursing, or could become pregnant and am not using effective birth control.I do not have severe confusion that would affect my participation in this study.My breast cancer was treated and has not spread.You have been in a study involving AR1001 before.My tests show positive for brain amyloid.You have previously had a PET scan that confirmed the presence of amyloid.You have a body mass index (BMI) higher than 35.I am HIV positive.I am currently taking medication like sildenafil.
Research Study Groups:
This trial has the following groups:- Group 1: Group A - Active Comparator
- Group 2: Group B - Placebo Comparator
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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)."
Answered by AI
Who else is applying?
What site did they apply to?
Accel Research Sites
Advanced Memory Research Institute of New Jersey
BTC of New Bedford
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I were hoping to see if I can get a different medicine.
PatientReceived 2+ prior treatments
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