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

Primary Purpose

Alzheimer Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Azeliragon
Placebo
Sponsored by
vTv Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Receptor for Advanced Glycation Endproducts (RAGE), ADAS-cog, CDR-sb

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tucson Neuroscience Research
  • Institute for Neurodegenerative Disorders
  • JEM Research Institute
  • Brain Matters Research
  • Jacksonville Center for Clinical Research
  • Charter Research
  • Alzheimer's Research and Treatment Center
  • ClinCloud
  • Synexus Clinical Research US
  • Emerald Coast Center for Neurological Disorders
  • Progressive Medical Research
  • The Roskamp Institute
  • Brain Matters Research
  • Emory Alzheimer's Clinical Research Unit
  • NeuroStudies.net LLC
  • IU Health Partners, Adult Neurology Clinic
  • Memory Center / Hattiesburg Clinic
  • Millennium Psychiatric Associates
  • The Cognitive and Research Center of New Jersey
  • Clarity Clinical Research
  • Neurological Associates of Long Island
  • ANI Neurology dba Alzheimer's Memory Center
  • Raleigh Neurology Associates
  • Wake Forest School of Medicine
  • The Ohio State University
  • Summit Research Network
  • Center for Cognitive Health
  • Okanagan Clinical Trials Ltd.
  • True North Clinical Research Inc.
  • True North Clinical Research Inc.
  • Recherches Neuro-Hippocampe
  • Recherches Neuro-Hippocampe Inc.
  • Q&T Research Sherbrooke Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Azeliragon

Placebo

Arm Description

Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)

Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at 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.
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.

Full Information

First Posted
May 31, 2019
Last Updated
December 21, 2021
Sponsor
vTv Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03980730
Brief Title
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Acronym
Elevage
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why Stopped
for business reasons
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
vTv Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Receptor for Advanced Glycation Endproducts (RAGE), ADAS-cog, CDR-sb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azeliragon
Arm Type
Experimental
Arm Description
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
Intervention Type
Drug
Intervention Name(s)
Azeliragon
Other Intervention Name(s)
TTP488
Intervention Description
Azeliragon 5 mg capsule administered orally, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo capsule administered orally, once daily
Primary Outcome Measure Information:
Title
Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6
Description
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
Time Frame
Baseline to Month 6
Secondary Outcome Measure Information:
Title
Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6
Description
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.
Time Frame
Baseline to Month 6
Title
Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6
Description
Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Time Frame
Baseline to Month 6
Title
Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6
Description
The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
Time Frame
Baseline to Month 6
Title
Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.
Description
The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.
Time Frame
Baseline to Month 6
Other Pre-specified Outcome Measures:
Title
Count and Percentage of Subjects With Treatment-emergent Adverse Events
Time Frame
Baseline to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Charter Research
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
ClinCloud
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Synexus Clinical Research US
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emerald Coast Center for Neurological Disorders
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
The Roskamp Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
Country
United States
Facility Name
Brain Matters Research
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997
Country
United States
Facility Name
Emory Alzheimer's Clinical Research Unit
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
NeuroStudies.net LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
IU Health Partners, Adult Neurology Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Memory Center / Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Millennium Psychiatric Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63132
Country
United States
Facility Name
The Cognitive and Research Center of New Jersey
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Clarity Clinical Research
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
Neurological Associates of Long Island
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
ANI Neurology dba Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Cognitive Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Okanagan Clinical Trials Ltd.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
True North Clinical Research Inc.
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1M7
Country
Canada
Facility Name
True North Clinical Research Inc.
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
Recherches Neuro-Hippocampe
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z IG3
Country
Canada
Facility Name
Recherches Neuro-Hippocampe Inc.
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8T 8J1
Country
Canada
Facility Name
Q&T Research Sherbrooke Inc
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1J 2G2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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