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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03980730
Recruitment Status : Terminated (for business reasons)
First Posted : June 10, 2019
Results First Posted : January 21, 2022
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics

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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Azeliragon Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. Count and Percentage of Subjects With Treatment-emergent Adverse Events [ Time Frame: Baseline to Month 6 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03980730


Locations
Show Show 33 study locations
Sponsors and Collaborators
vTv Therapeutics
  Study Documents (Full-Text)

Documents provided by vTv Therapeutics:
Study Protocol  [PDF] April 29, 2019
Statistical Analysis Plan  [PDF] December 8, 2020

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Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT03980730    
Other Study ID Numbers: TTP488-305
First Posted: June 10, 2019    Key Record Dates
Results First Posted: January 21, 2022
Last Update Posted: January 21, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by vTv Therapeutics:
Receptor for Advanced Glycation Endproducts (RAGE)
ADAS-cog
CDR-sb
Additional relevant MeSH terms:
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Alzheimer Disease
Glucose Intolerance
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases