Study Stopped
for business reasons
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Elevage
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
1 other identifier
interventional
43
2 countries
33
Brief Summary
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 alzheimer-disease
Started Jun 2019
Shorter than P25 for phase_2 alzheimer-disease
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 10, 2019
CompletedStudy Start
First participant enrolled
June 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2021
CompletedResults Posted
Study results publicly available
January 21, 2022
CompletedJanuary 21, 2022
December 1, 2021
1.4 years
May 31, 2019
November 16, 2021
December 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
Baseline to Month 6
Secondary Outcomes (4)
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
Baseline to Month 6
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Baseline to Month 6
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
Baseline to Month 6
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
Baseline to Month 6
Other Outcomes (1)
Count and Percentage of Subjects With Treatment-emergent Adverse Events
Baseline to Month 6
Study Arms (2)
Azeliragon
EXPERIMENTALAzeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Placebo
PLACEBO COMPARATORMatching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Interventions
Azeliragon 5 mg capsule administered orally, once daily
Eligibility Criteria
You may qualify if:
- Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
- Mini Mental State Examination (MMSE) score of 21-26, inclusive
- Clinical Dementia Rating global score of 0.5 or 1
- Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
- Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
- Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 2 months prior to screening
- Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
- Caregiver willing to participate and be able to attend clinic visits with patient
- Ability to ingest oral medications
You may not qualify if:
- Significant neurological or psychiatric disease other than Alzheimer's disease
- Previous clinical trial participation within 90 days of screening
- Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year of screening
- History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment
- Women of childbearing potential
- Uncontrolled blood pressure and/or blood pressure above 140/90
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- vTv Therapeuticslead
Study Sites (33)
Tucson Neuroscience Research
Tucson, Arizona, 85710, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Charter Research
Lady Lake, Florida, 32159, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33449, United States
ClinCloud
Maitland, Florida, 32751, United States
Synexus Clinical Research US
Orlando, Florida, 32806, United States
Emerald Coast Center for Neurological Disorders
Pensacola, Florida, 32514, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
The Roskamp Institute
Sarasota, Florida, 34243, United States
Brain Matters Research
Stuart, Florida, 34997, United States
Emory Alzheimer's Clinical Research Unit
Atlanta, Georgia, 30329, United States
NeuroStudies.net LLC
Decatur, Georgia, 30033, United States
IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana, 46202, United States
Memory Center / Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Millennium Psychiatric Associates
St Louis, Missouri, 63132, United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081, United States
Clarity Clinical Research
East Syracuse, New York, 13057, United States
Neurological Associates of Long Island
Lake Success, New York, 11042, United States
ANI Neurology dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607, United States
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Summit Research Network
Portland, Oregon, 97210, United States
Center for Cognitive Health
Portland, Oregon, 97225, United States
Okanagan Clinical Trials Ltd.
Kelowna, British Columbia, V1Y 1Z9, Canada
True North Clinical Research Inc.
Halifax, Nova Scotia, B3S 1M7, Canada
True North Clinical Research Inc.
Kentville, Nova Scotia, B4N 4K9, Canada
Recherches Neuro-Hippocampe
Ottawa, Ontario, K1Z IG3, Canada
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, J8T 8J1, Canada
Q&T Research Sherbrooke Inc
Sherbrooke, Quebec, J1J 2G2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP Clinical Operations
- Organization
- vTv Therapeutics LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 10, 2019
Study Start
June 27, 2019
Primary Completion
December 1, 2020
Study Completion
January 29, 2021
Last Updated
January 21, 2022
Results First Posted
January 21, 2022
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share