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Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease

NCT03625622•AriBio Co., Ltd.

View on ClinicalTrials.gov

Summary

A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.

Detailed Description

Alzheimer's Disease (AD) is the most prevalent neurodegenerative disorder in The United States affecting approximately 5.4 million Americans. AD is characterized by progressive loss in memory and as well as a decline in the ability to learn that is associated with neuronal death. Well known hallmarks of AD are neuritic plaques and neurofibrillary tangles and extensive inflammation. Currently, no treatment has been developed to fully cure or prevent the progression of dementia that is associated with AD. AR1001 is a polypharmacological drug candidate being developed as a treatment for AD and shows great potential with favorable attributes for a central nervous system (CNS) drug (i.e., high specificity and potency, as well as good pharmacokinetic, bioavailability, CNS penetration, and ensured safety). The clinical study of AR1001 aims to evaluate the efficacy and safety of AR1001 as a potential treatment for AD. Based on the preclinical results, AR1001 could be an effective treatment option with a mechanism of action that has not been explored for AD indication.

Eligibility

Age

55 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects aged 55-80 years at the time of signing the Informed Consent Form.
•2. Subjects (or subject's legally acceptable representative) and caregiver(s) who can sign an Informed Consent to participate in the study. Same caregiver(s) must assist the subject throughout the entire duration of the study.
•3. Subjects who have a diagnosis of probable Alzheimer's disease according to the NIA-AA (National Institute of Aging and Alzheimer's Associations, 2011) criteria with mild to moderate dementia (stage 4 - 5) at screening.
•4. Subjects who have mild-to-moderate cognitive impairment with MMSE Score of 16-26 at screening.
•5. Subjects who have an MRI (either 1.5T or 3T) or CT scan performed after onset of symptoms and prior to randomization with findings consistent with the diagnosis of dementia due to Alzheimer's disease and without any other clinically significant comorbid pathologies.
•6. Subjects who have one (or more) identified adult study partner(s) who, in the opinion of the investigator, has sufficient contact with and knowledge about the subject as to be able to report knowledgeably about the subject's safety, compliance and adherence, cognition, function, and behavior.

Exclusion Criteria

•1. Subjects who are female who are pregnant, nursing, or of childbearing potential and not practicing effective contraception.
•2. Subjects who have signs of delirium.
•3. Subjects who have had a cortical stroke within the preceding 2 years.
•4. Subjects who have any diagnosis of dementia other than that related to Alzheimer's Disease, including concomitant vascular dementia.
•5. Subjects who have a PET scan performed after onset of symptoms with negative amyloid results.
•6. Subjects with a history of myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or IV heart failure or stroke within the last 12 months.
•7. Subjects with uncontrolled hypertension (systolic blood pressure \>160mm Hg or diastolic blood pressure \> 95mm Hg) or hypotension (systolic blood pressure \<90mm Hg or diastolic blood pressure \<50mm Hg).
•8. Subjects who have clinically significant renal impairment (creatinine \> 1.5x ULN) or hepatic impairment (AST or ALT \> 2.5x ULN or total bilirubin \> 1.5x ULN).
•9. Subjects who have history of cancer or malignant tumor within 5 years prior to screening with the exception of:
•1. Basal or squamous cell carcinoma of the skin or cervical dysplasia which has been adequately treated.
+13 more criteria

Locations (21)

Advanced Clinical Research, Inc.

Banning, California, United States

Northern California Research

Sacramento, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

Meridien Research

Lakeland, Florida, United States

Meridien - Maitland

Maitland, Florida, United States

The Neurology Research Group

Miami, Florida, United States

Accelerated Enrollment Solutions (AES)

Orlando, Florida, United States

IMIC, Inc

Palmetto Bay, Florida, United States

Meridien Research - Spring Hill

Spring Hill, Florida, United States

Meridien Research - St Petersburg

St. Petersburg, Florida, United States

Key Dates

Start Date

April 1, 2019

Primary Completion Date

December 22, 2020

Completion Date

June 28, 2021

Last Updated

July 21, 2021

Enrollment

210

ACTUAL participants

Conditions

Mild to Moderate Alzheimer's Disease

Interventions

AR1001

DRUG

Placebo

DRUG

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Mild to Moderate Alzheimer's Disease

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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