Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE August 8, 2018
First Posted Date  ICMJE August 10, 2018
Last Update Posted Date April 1, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
  • ADAS-Cog 13 [ Time Frame: 26 weeks ]
    Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26
  • ADCS-CGIC [ Time Frame: 26 weeks ]
    Change of ADCS-CGIC (Alzheimer's disease Cooperative Study-Clinical Global Impression of Change)
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
ADAS-Cog [ Time Frame: 26 weeks ]
Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26
Change History Complete list of historical versions of study NCT03625622 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2019)
  • MMSE-2 [ Time Frame: 26 weeks ]
    Change of MMSE (Mini-mental status examination) from baseline at Week 26
  • NPI [ Time Frame: 26 weeks ]
    Changes of NPI (Neuropsychiatric Inventory) from baseline at Week 26
  • GDS [ Time Frame: 26 weeks ]
    Changes of GDS (Geriatric Depression Scale) from baseline at Week 26
  • C-SSRS [ Time Frame: 26 weeks ]
    Changes of C-SSRS (Columbia Suicide Severity Rating Scale) from baseline at Week 26
  • QOL-AD [ Time Frame: 26 weeks ]
    Changes of QOL-AD (Quality of Life in Alzheimer's Disease) from baseline at Week 26
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • ADCS-ADL [ Time Frame: 26 weeks ]
    Change of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) from baseline at Week 26
  • MMSE [ Time Frame: 26 weeks ]
    Change of MMSE (Mini-mental status examination) from baseline at Week 26
  • CDR-SOB [ Time Frame: 26 weeks ]
    Changes of CDR-SOB (Clinical Dementia Rating-Sum of Boxes) from baseline at Week 26
  • NPI [ Time Frame: 26 weeks ]
    Changes of NPI (Neuropsychiatric Inventory) from baseline at Week 26
  • GDS [ Time Frame: 26 weeks ]
    Changes of GDS (Geriatric Depression Scale) from baseline at Week 26
  • C-SSRS [ Time Frame: 26 weeks ]
    Changes of C-SSRS (Columbia Suicide Severity Rating Scale) from baseline at Week 26
  • QOL-AD [ Time Frame: 26 weeks ]
    Changes of QOL-AD (Quality of Life in Alzheimer's Disease) from baseline at Week 26
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Mild to Moderate Alzheimer's Disease
Intervention  ICMJE
  • Drug: AR1001
    AR1001 Active Oral Tablet
  • Drug: Placebo
    Placebo Oral Tablet
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo, orally administered once daily for 26 weeks.
    Intervention: Drug: Placebo
  • Active Comparator: AR1001 - 10 mg
    Active, AR1001 - 10 mg, orally administered once daily for 26 weeks.
    Intervention: Drug: AR1001
  • Active Comparator: AR1001 - 30 mg
    Active, AR1001 - 30 mg, orally administered once daily for 26 weeks.
    Intervention: Drug: AR1001
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Fred Kim, BA 7345168732 fredkim@aribiousa.com
Contact: Jim Rock, MS, MBA ‭8582917539 jimrock@aribiousa.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03625622
Other Study ID Numbers  ICMJE AR1001-ADP2-US01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AriBio Co., Ltd.
Study Sponsor  ICMJE AriBio Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: James Rock, MS, MBA SVP of global development
PRS Account AriBio Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP