Trial record 2 of 2 for:
Azeliragon | Alzheimer Disease
Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (STEADFAST)
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| ClinicalTrials.gov Identifier: NCT02080364 |
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Recruitment Status :
Terminated
(Not due to safety but due to a lack of efficacy at the 5 mg azeliragon dose.)
First Posted : March 6, 2014
Last Update Posted : June 8, 2018
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Sponsor:
vTv Therapeutics
Information provided by (Responsible Party):
vTv Therapeutics
- Study Details
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Brief Summary:
This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 18 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: Azeliragon Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 880 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, Multi-center Registration Trial to Evaluate the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease Receiving Acetylcholinesterase Inhibitors and/or Memantine |
| Actual Study Start Date : | April 2015 |
| Actual Primary Completion Date : | June 1, 2018 |
| Actual Study Completion Date : | June 1, 2018 |
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 |
|---|---|
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Experimental: Azeliragon 5mg
Azeliragon (TTP488) 5mg orally once daily for 18 months
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Drug: Azeliragon
Azeliragon 5mg administered orally, once daily for 18 months
Other Name: TTP488 |
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Placebo Comparator: Placebo
Placebo orally once daily for 18 months
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Drug: Placebo
Placebo administered orally, once daily for 18 months |
Primary Outcome Measures :
- Change from Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) total score [ Time Frame: 18 months ]
- Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) [ Time Frame: 18 months ]
Secondary Outcome Measures :
- Change from Baseline in Magnetic Resonance Imaging (MRI) brain volumetric measures [ Time Frame: 18 months ]
- Change from Baseline in Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Scan [ Time Frame: 18 months ]
- Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: 18 months ]
- Change from Baseline in Mini-Mental State Examination (MMSE) [ Time Frame: 18 months ]
- Change from Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL) [ Time Frame: 18 months ]
- Change from Baseline in Continuous Oral Word Association Task (COWAT) [ Time Frame: 18 month ]
- Change from Baseline in Category Fluency Test (CFT) [ Time Frame: 18 months ]
- Change from Baseline in Resource Utilization in Dementia (RUD) [ Time Frame: 18 months ]
- Change from Baseline in Dementia Quality of Life (DEMQOL) [ Time Frame: 18 months ]
- Change from Baseline in Plasma Amyloid Beta [ Time Frame: 18 months ]
- Proportion of Responders based on ADAS-cog [ Time Frame: 18 months ]
- Proportion of Responders based on CDR-SB [ Time Frame: 18 months ]
- Adverse Events [ Time Frame: 21 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years and older (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
- Rosen-Modified Hachinski Ischemia Score less than or equal to 4
- 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 3 months prior to randomization
- 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
- Participants with evidence or history of severe drug allergies (resulting in dyspnea or severe rash).
- Any contraindications to MRI (e.g., clinically significant claustrophobia, non-removable ferromagnetic implants). Patients with contraindications to MRI may undergo computed tomography (CT) on approval by sponsor.
- Any contraindications to the FDG-PET study (e.g. allergy to any component of the FDG dose) in the cohort undergoing a PET scan.
- Previous exposure to investigational or non-investigational therapies for Alzheimer's disease within 6 months 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 treatment
- Women of childbearing potential
- Uncontrolled blood pressure and/or blood pressure above 160/100
- Prescription medical food intended for dietary management of the metabolic processes associated with Alzheimer's disease.
- Diagnosis or history of cerebrovascular stroke, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage.
- Patients with unstable, uncontrolled diabetes (HbA1c > 7.7%) and those requiring insulin.
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): NCT02080364
Show 115 Study Locations
Sponsors and Collaborators
vTv Therapeutics
Investigators
| Study Director: | Aaron H Burstein, PharmD | vTv Therapeutics |
Additional Information:
| Responsible Party: | vTv Therapeutics |
| ClinicalTrials.gov Identifier: | NCT02080364 History of Changes |
| Other Study ID Numbers: |
TTP488-301 |
| First Posted: | March 6, 2014 Key Record Dates |
| Last Update Posted: | June 8, 2018 |
| Last Verified: | June 2018 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by vTv Therapeutics:
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Alzheimer's disease RAGE ADAS-cog CDR-sb |
Additional relevant MeSH terms:
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Alzheimer Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Dementia |
Tauopathies Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |