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Azeliragon for Mild Alzheimer's and Diabetes (Elevage)

Recruiting

This Phase II/III clinical trial will evaluate the efficacy and safety of the experimental drug azeliragon in adults with mild Alzheimer's disease and impaired glucose tolerance (at a level associated with type 2 diabetes).

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
June 27, 2019
July 2023
300

  • Diagnosis of probable Alzheimer's disease with documented evidence of disease progression
  • Mini-Mental State Examination score of 21 to 26
  • Clinical Dementia Rating global score of 0.5 or 1
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale of 10 or more
  • Brain magnetic resonance imaging consistent with diagnosis of probable Alzheimer's
  • Use of Alzheimer's drugs must be on stable dose for at least 2 months prior to screening
  • Hemoglobin A1c level of 6.5% to 9.5%
  • Caregiver who can attend clinic visits with the participant
  • Ability to ingest oral medications

  • Significant neurological or psychiatric disease other than Alzheimer's
  • Previous clinical trial participation within 90 days of screening
  • Previous exposure to disease-modifying therapy for Alzheimer's disease within 1 year of screening
  • History of cancer within last 5 years except treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or nonprogressive prostate cancer not requiring current treatment
  • Women of childbearing potential
  • Uncontrolled blood pressure and/or blood pressure above 140/90 mm Hg
  • Participants receiving medications that may negatively impact cognitive function
  • History of diabetic ketoacidosis within the past year
  • History of chronic pancreatitis
  • Stage 4 kidney disease
  • Use of insulin therapy

Azeliragon is a small molecule drug being developed as a potential treatment for mild to moderate Alzheimer's disease. Participants will be randomly assigned to receive either 5 mg of the study drug or placebo for 9 months, in Phase II, or for 21 months, in Phase III.

For more information on this clinical trial or study sites, call 336-888-0435 or email clinicaltrials@vtvtherapeutics.com.

Name City State Zip Status Primary Contact
Tucson Neuroscience Research
Tucson Arizona 85710 Suspended

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510 Suspended

JEM Research Institute
Atlantis Florida 33462 Recruiting

Brain Matters Research
Delray Beach Florida 33445 Recruiting

Jacksonville Center for Clinical Research
Jacksonville Florida 32216 Recruiting

Charter Research
Lady Lake Florida 32159 Recruiting

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 Recruiting

ClinCloud
Maitland Florida 32751 Recruiting

Synexus Clinical Research US
Orlando Florida 32806 Recruiting

Emerald Coast Center for Neurological Disorders
Pensacola Florida 32514 Recruiting

Progressive Medical Research
Port Orange Florida 32127 Recruiting

The Roskamp Institute
Sarasota Florida 34243 Recruiting

Brain Matters Research
Stuart Florida 34997 Recruiting

Emory Alzheimer's Clinical Research Unit
Atlanta Georgia 30329 Suspended

NeuroStudies.net LLC
Decatur Georgia 30033 Suspended

IU Health Partners, Adult Neurology Clinic
Indianapolis Indiana 46202 Suspended

Memory Center / Hattiesburg Clinic
Hattiesburg Mississippi 39401 Recruiting

Millennium Psychiatric Associates
Saint Louis Missouri 63132 Recruiting

The Cognitive and Research Center of New Jersey
Springfield New Jersey 07081 Recruiting

Albuquerque Neuroscience Inc.
Albuquerque New Mexico 87109 Withdrawn

Clarity Clinical Research
East Syracuse New York 13057 Recruiting

Neurological Associates of Long Island
Lake Success New York 11042 Recruiting

ANI Neurology dba Alzheimer's Memory Center
Charlotte North Carolina 28270 Recruiting

Raleigh Neurology Associates
Raleigh North Carolina 27607 Recruiting

M3 Wake Research
Raleigh North Carolina 27612 Withdrawn

Wake Forest School of Medicine
Winston-Salem North Carolina 27157 Suspended

The Ohio State University
Columbus Ohio 43210 Recruiting

Summit Research Network
Portland Oregon 97210 Suspended

Center for Cognitive Health
Portland Oregon 97225 Recruiting

Okanagan Clinical Trials Ltd.
Kelowna British Columbia V1Y 1Z9 Recruiting

True North Clinical Research Inc.
Halifax Nova Scotia B3S 1M7 Suspended

True North Clinical Research Inc.
Kentville Nova Scotia B4N 4K9 Recruiting

Recherches Neuro-Hippocampe
Ottawa Ontario K1Z IG3 Recruiting

Recherches Neuro-Hippocampe Inc.
Gatineau Quebec J8T 8J1 Recruiting

Q&T Research Sherbrooke Inc
Sherbrooke Quebec J1J 2G2 Recruiting

vTv Therapeutics

Name Phone Email
Ann Gooch, PhD 336-888-0435 clinicaltrials@vtvtherapeutics.com

NCT03980730

Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance