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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03980730 |
|
Recruitment Status :
Recruiting
First Posted : June 10, 2019
Last Update Posted : January 14, 2020
|
Sponsor:
vTv Therapeutics
Information provided by (Responsible Party):
vTv Therapeutics
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| 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 :
- 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.
Secondary Outcome Measures :
- 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 ]
Other Outcome Measures:
- 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 ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| Contact: Ann Gooch, PhD | 336-888-0435 | clinicaltrials@vtvtherapeutics.com |
Locations
Show 34 study locations
Sponsors and Collaborators
vTv Therapeutics
| 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: | January 14, 2020 |
| Last Verified: | January 2020 |
| 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 |
Keywords provided by vTv Therapeutics:
|
Receptor for Advanced Glycation Endproducts (RAGE) ADAS-cog CDR-sb |
Additional relevant MeSH terms:
|
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 |