Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (Elevage)
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ClinicalTrials.gov Identifier: NCT03980730 |
Recruitment Status :
Terminated
(for business reasons)
First Posted : June 10, 2019
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease | Drug: Azeliragon Drug: Placebo | Phase 2 |
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 26, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Azeliragon
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
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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)
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Drug: Placebo
Matching placebo capsule administered orally, once daily |
- 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
- 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
- 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.
- 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.
- 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.
- 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
- Part 1: Change from Baseline in estimated glomerular filtration rate (eGFR) at Month 6 [ Time Frame: 6 months ]
- 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
- 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.
- Part 2: Change from Baseline in Amsterdam-IADL score at Month 18 [ Time Frame: 18 months ]
- 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.
- Part 2: Change from Baseline in eGFR at Month 18 [ Time Frame: 18 months ]
- Part 2: Change from Baseline in whole brain volume at Month 18 [ Time Frame: 18 months ]
- Proportions of subjects with treatment-emergent adverse events [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 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) ]
- 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) ]
- 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) ]
- 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.
- 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.
- Part 2: Change from Baseline in plasma concentrations of Aβ species at Month 18 [ Time Frame: 18 months ]
- Part 2: Change from Baseline in brain MRI (hippocampal, ventricular) volumetric measures at Month 18 [ Time Frame: 18 months ]

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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 |
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

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

Responsible Party: | vTv Therapeutics |
ClinicalTrials.gov Identifier: | NCT03980730 |
Other Study ID Numbers: |
TTP488-305 |
First Posted: | June 10, 2019 Key Record Dates |
Last Update Posted: | February 2, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Receptor for Advanced Glycation Endproducts (RAGE) ADAS-cog CDR-sb |
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 |