Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (Elevage)

December 21, 2021 updated by: vTv Therapeutics

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Okanagan Clinical Trials Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3S 1M7
        • True North Clinical Research Inc.
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • True North Clinical Research Inc.
    • Ontario
      • Ottawa, Ontario, Canada, K1Z IG3
        • Recherches Neuro-Hippocampe
    • Quebec
      • Gatineau, Quebec, Canada, J8T 8J1
        • Recherches Neuro-Hippocampe Inc.
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • Q&T Research Sherbrooke Inc
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Tucson Neuroscience Research
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research
      • Lady Lake, Florida, United States, 32159
        • Charter Research
      • Lake Worth, Florida, United States, 33449
        • Alzheimer's Research and Treatment Center
      • Maitland, Florida, United States, 32751
        • ClinCloud
      • Orlando, Florida, United States, 32806
        • Synexus Clinical Research US
      • Pensacola, Florida, United States, 32514
        • Emerald Coast Center For Neurological Disorders
      • Port Orange, Florida, United States, 32127
        • Progressive Medical Research
      • Sarasota, Florida, United States, 34243
        • The Roskamp Institute
      • Stuart, Florida, United States, 34997
        • Brain Matters Research
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory Alzheimer's Clinical Research Unit
      • Decatur, Georgia, United States, 30033
        • NeuroStudies.net LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • IU Health Partners, Adult Neurology Clinic
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Memory Center / Hattiesburg Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63132
        • Millennium Psychiatric Associates
    • New Jersey
      • Springfield, New Jersey, United States, 07081
        • The Cognitive and Research Center of New Jersey
    • New York
      • East Syracuse, New York, United States, 13057
        • Clarity Clinical Research
      • Lake Success, New York, United States, 11042
        • Neurological Associates of Long Island
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • ANI Neurology dba Alzheimer's Memory Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Research Network
      • Portland, Oregon, United States, 97225
        • Center for Cognitive Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azeliragon
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Drug: Azeliragon
Azeliragon 5 mg capsule administered orally, once daily
Other Names:
  • TTP488
Placebo Comparator: Placebo
Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Drug: Placebo
Matching placebo capsule administered orally, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
Time Frame: Baseline to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
Time Frame: Baseline to Month 6
The Amsterdam-Instrumental Activities of Daily Living score is calculated from a questionnaire consisting of 70 items in seven categories using an item response theory method of scoring. Scores range from 20 to 80 where lower scores indicate greater functional impairment.
Baseline to Month 6
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Time Frame: Baseline to Month 6
Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Baseline to Month 6
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
Time Frame: Baseline to Month 6
The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Baseline to Month 6
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
Time Frame: Baseline to Month 6
The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.
Baseline to Month 6

Other Outcome Measures

Outcome Measure
Time Frame
Count and Percentage of Subjects With Treatment-emergent Adverse Events
Time Frame: Baseline to Month 6
Baseline to Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

vTv Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTP488-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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