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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03625622
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
AriBio Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Alzheimer's Disease Drug: AR1001 Drug: Placebo Phase 2

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind for study site and participants
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo, orally administered once daily for 26 weeks.
Drug: Placebo
Placebo Oral Tablet

Active Comparator: AR1001 - 10 mg
Active, AR1001 - 10 mg, orally administered once daily for 26 weeks.
Drug: AR1001
AR1001 Active Oral Tablet

Active Comparator: AR1001 - 30 mg
Active, AR1001 - 30 mg, orally administered once daily for 26 weeks.
Drug: AR1001
AR1001 Active Oral Tablet




Primary Outcome Measures :
  1. ADAS-Cog 13 [ Time Frame: 26 weeks ]
    Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26

  2. ADCS-CGIC [ Time Frame: 26 weeks ]
    Change of ADCS-CGIC (Alzheimer's disease Cooperative Study-Clinical Global Impression of Change)


Secondary Outcome Measures :
  1. MMSE-2 [ Time Frame: 26 weeks ]
    Change of MMSE (Mini-mental status examination) from baseline at Week 26

  2. NPI [ Time Frame: 26 weeks ]
    Changes of NPI (Neuropsychiatric Inventory) from baseline at Week 26

  3. GDS [ Time Frame: 26 weeks ]
    Changes of GDS (Geriatric Depression Scale) from baseline at Week 26

  4. C-SSRS [ Time Frame: 26 weeks ]
    Changes of C-SSRS (Columbia Suicide Severity Rating Scale) from baseline at Week 26

  5. QOL-AD [ Time Frame: 26 weeks ]
    Changes of QOL-AD (Quality of Life in Alzheimer's Disease) from baseline at Week 26

  6. Treatment related adverse events [ Time Frame: 26 weeks ]
    Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects aged 55-75 years at the time of signing the Informed Consent form.
  2. Subjects (or subject's legally acceptable representative) and caregivers who can sign an Informed Consent to participate in the study.
  3. Subjects who have a diagnosis of probable mild-to-moderate Alzheimer's disease according to the NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria at the screening and baseline visits.
  4. Subjects who have an MMSE Score of 16-26 at the screening and baseline visits.
  5. Subjects who have an MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease 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 knowledgably 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 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 uncontrolled cardiac disease or hypertension.
  6. Subjects who have clinically significant renal or hepatic impairment.
  7. Subjects who have cancer or a malignant tumor, untreated thyroid disorder, or a history of seizure disorder.
  8. Subjects who are being treated, or likely to require treatment during the study, with any medications prohibited by the study protocol.
  9. Subjects who have received any investigational drug within the previous 30 days.
  10. Subjects who have a clinically significant abnormal result in laboratory tests, as determined by the Investigator.
  11. Subjects with any current psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the subject´s ability to complete the study.
  12. Subjects who have not been on a stable dose of anti-dementia therapy for at least 60 days prior to dosing, or intend to start anti-dementia therapy during the double-blind portion of the study.
  13. Subjects who currently take an alpha-1 blocker (e.g., tamsulosin).
  14. Subjects who currently take any other phosphodiesterase type 5 (PDE-5) inhibitors.
  15. Subjects who have known history, or suspected hypersensitivity to any excipients used in the study.
  16. Subjects with current use of nitrate agents.
  17. Subjects who are currently receiving (or unable to stop use for at least 21 days [3 weeks] prior to receiving the first dose of the AR1001 and throughout the study) prescription or non prescription medications or other products known to be moderate or potent inhibitors/inducers of CYP3A4.
  18. Subjects who have had any intake of grapefruit, grapefruit juice, Seville oranges, Seville orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of the first administration of the AR1001 and throughout the study.
  19. Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03625622


Contacts
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Contact: Fred Kim, BA 7345168732 fredkim@aribiousa.com
Contact: Jim Rock, MS, MBA ‭8582917539 jimrock@aribiousa.com

Locations
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United States, California
Advanced Clinical Research, Inc. Recruiting
Banning, California, United States, 92220
Contact: Judith Kirstein, MD    951-755-0224    jkirstein@acr-research.com   
Northern California Research Recruiting
Sacramento, California, United States, 95821
Contact: Douglas Young, MD    916-484-0500    3840.md@norcare.net   
United States, Florida
Meridien Research Recruiting
Lakeland, Florida, United States, 33805
Contact: James Anderson, MD    863-940-2087    jandersen@meridienresearch.net   
Meridien - Maitland Recruiting
Maitland, Florida, United States, 32751
Contact: Eva-Maria Heurich, DO    407-644-1165    eheurich@meridienresearch.net   
IMIC, Inc Recruiting
Palmetto Bay, Florida, United States, 33157
Contact: Evelyn Lopez-Brignoni, MD    786-310-7477    evelyn@aktamedika.com   
Meridien Research - St Petersburg Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Gigi Lefebvre, MD    727-347-8839    glefebvre@meridienresearch.net   
Meridien Research - Spring Hill Recruiting
Spring Hill, Florida, United States, 34609
Contact: Richard Powell, MD    352-597-8839    rpowell@meridienresearch.net   
Meridien Research - Tampa Recruiting
Tampa, Florida, United States, 33634
Contact: Cynthia Huffman, MD    813-877-8839    chuffman@meridienresearch.net   
United States, Idaho
Advanced Clinical Research Recruiting
Meridian, Idaho, United States, 83642
Contact: Mark Turner, MD    208-377-8653    mturner@acr-research.com   
United States, Ohio
Rapid Medical Research Recruiting
Beachwood, Ohio, United States, 44122
Contact: Toby Briskin, MD    216-682-0320    toby.briskin@rapidmedicalresearch.com   
United States, Oklahoma
Lynn Health Science Institute Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Carl Griffin, MD    405-602-3926    cgriffin@lhsi.net   
United States, South Carolina
Palmetto Clinical Research Recruiting
Summerville, South Carolina, United States, 29485
Contact: Robert M Carlile, MD    843-851-7098    rmcarlile@palmettoclinicalresearch.com   
United States, Texas
Advanced Clinical Research - Cedar Park Recruiting
Cedar Park, Texas, United States, 78613
Contact: Mark Carlson, MD    512-553-1921    mcarlson@acr-research.com   
Principal Investigator: Mark Carlson, MD         
FMC Science Recruiting
Lampasas, Texas, United States, 76550
Contact: James Cain, MD    512-556-4130    jecain@fmcscience.com   
United States, Utah
Advanced Clinical Research, Inc. Recruiting
West Jordan, Utah, United States, 84088
Contact: Barbara E Rizzardi, MD    801-542-8190    brizzardi@acr-research.com   
Sponsors and Collaborators
AriBio Co., Ltd.
Investigators
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Study Director: James Rock, MS, MBA SVP of global development

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Responsible Party: AriBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT03625622     History of Changes
Other Study ID Numbers: AR1001-ADP2-US01
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AriBio Co., Ltd.:
Alzheimer's disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders