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AR1001 for Mild to Moderate Alzheimer's Disease

Recruiting

This Phase II trial will investigate the efficacy and safety of the investigational drug AR1001 in older adults with mild to moderate Alzheimer's disease for 26 weeks.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 80 Years All No
January 15, 2019
August 1, 2020
210

  • Diagnosis of probable mild to moderate Alzheimer's disease
  • Mini-Mental State Examination Score of 16 to 26
  • Magnetic resonance imaging or computed tomography scan performed within the past year, with findings consistent with an Alzheimer's disease diagnosis without any other clinically significant conditions
  • One (or more) adult study partner(s) who can report about the participant's safety, compliance and adherence, cognition, function, and behavior

  • Pregnant, nursing, or of childbearing potential and not practicing effective contraception
  • Signs of delirium
  • Cortical stroke within the past 2 years
  • Diagnosis of dementia other than Alzheimer's disease, including vascular dementia
  • Uncontrolled heart disease or high blood pressure
  • Clinically significant kidney or liver impairment
  • Cancer or a malignant tumor, untreated thyroid disorder, or a history of seizure disorder
  • Taken an investigational drug within the past 30 days
  • Significant abnormal result in laboratory tests
  • Current psychiatric diagnosis that could interfere with study participation or results
  • If taking anti-dementia drugs, must be on stable dose for at least 60 days prior to taking study drug
  • Prohibited medications: alpha-1 blockers (e.g., tamsulosin), PDE5 inhibitors, nitrate agents
  • History or suspected hypersensitivity to any ingredients used in the study drug
  • Prescription or non-prescription medications or other products known to be moderate or potent inhibitors/inducers of the enzyme CYP3A4 (unless able to stop use for at least 3 weeks prior to receiving the study drug and throughout the study)
  • Intake of grapefruit, grapefruit juice, Seville oranges or orange marmalade, or other products containing grapefruit or Seville oranges within 7 days of study drug administration and throughout the study

AR1001 is an experimental small molecule drug being investigated as a possible treatment for Alzheimer's disease. Participants in this study will be randomly assigned to take an oral tablet of the study drug or a placebo for 26 weeks. The study drug is being tested in both 10-mg and 30-mg doses. 

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

AriBio Co., Ltd.

Name Role Affiliation
James Rock Study Director AriBio Co., Ltd.

Name Phone Email
Fred Kim 734-516-8732 fredkim@aribiousa.com
Jim Rock ‭858-291-7539 jimrock@aribiousa.com

NCT03625622

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