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

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ClinicalTrials.gov Identifier: NCT03980730
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : August 2, 2019
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 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : July 2023

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: 6 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  2. Part 2: Change from Baseline in the ADAS-cog14 at Month 18 [ Time Frame: 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  3. Part 2: Change from Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 18 [ Time Frame: 18 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.


Secondary Outcome Measures :
  1. Part 1: Change from Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6 [ Time Frame: 6 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.

  2. Part 1: Change from Baseline in the Functional Activities Questionnaire (FAQ) at Month 6 [ Time Frame: 6 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.

  3. Part 1: Change from Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6 [ Time Frame: 6 months ]
    The A-IADL total score is calculated using an item response theory method of scoring and lower scores indicate greater functional impairment

  4. Part 1: Change from Baseline in estimated glomerular filtration rate (eGFR) at Month 6 [ Time Frame: 6 months ]
  5. Part 2: Responder status at Months 6, 12, and 18 based on the ADAS-cog14 [ Time Frame: 6, 12, 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  6. Part 2: Change from Baseline in FAQ score at Month 18 [ Time Frame: 18 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.

  7. Part 2: Change from Baseline in Amsterdam-IADL score at Month 18 [ Time Frame: 18 months ]
  8. Part 2: Change from Baseline in MMSE score at Month 18 [ Time Frame: 18 months ]
    MMSE scores range from 0-30 with lower scores indicating greater cognitive impairment.

  9. Part 2: Change from Baseline in eGFR at Month 18 [ Time Frame: 18 months ]
  10. Part 2: Change from Baseline in whole brain volume at Month 18 [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Proportions of subjects with treatment-emergent adverse events [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  2. Proportions of subjects with treatment-emergent abnormal clinical laboratory values [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  3. Proportions of subjects with abnormal values or changes in vital signs measures of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  4. Proportions of subjects with treatment-emergent 12-lead ECG results of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  5. Part 2: Change from Baseline at Month 18 for Neuropsychiatric Inventory [ Time Frame: 18 months ]
    Scores range from 0-144 with higher scores indicating a greater presence of neuropsychiatric symptoms.

  6. Part 2: Change from Baseline at Month 18 Dementia Quality of Life (DEMQOL-proxy) [ Time Frame: 18 months ]
    Higher scores indicate better health related quality of life.

  7. Part 2: Change from Baseline in plasma concentrations of Aβ species at Month 18 [ Time Frame: 18 months ]
  8. Part 2: Change from Baseline in brain MRI (hippocampal, ventricular) volumetric measures at Month 18 [ Time Frame: 18 months ]


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


Contacts
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Contact: Ann Gooch, PhD 336-888-0435 clinicaltrials@vtvtherapeutics.com

Locations
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United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Charter Research Recruiting
Lady Lake, Florida, United States, 32159
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
ClinCloud Recruiting
Maitland, Florida, United States, 32751
The Roskamp Institute Recruiting
Sarasota, Florida, United States, 34243
United States, Georgia
NeuroStudies.net LLC Recruiting
Decatur, Georgia, United States, 30033
United States, Mississippi
Memory Center / Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
United States, New Jersey
The Cognitive and Research Center of New Jersey Recruiting
Springfield, New Jersey, United States, 07081
United States, New Mexico
Albuquerque Neuroscience Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
Clarity Clinical Research Recruiting
East Syracuse, New York, United States, 13057
Neurological Associates of Long Island Recruiting
Lake Success, New York, United States, 11042
United States, North Carolina
ANI Neurology dba Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
ANI Neurology, PLLC Recruiting
Charlotte, North Carolina, United States, 28270
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
United States, Oregon
Summit Research Network Recruiting
Portland, Oregon, United States, 97210
Center for Cognitive Health Recruiting
Portland, Oregon, United States, 97225
Sponsors and Collaborators
vTv Therapeutics

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Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT03980730     History of Changes
Other Study ID Numbers: TTP488-305
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
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