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Trial record 2 of 3 for:    Alzheimer's disease AND RAGE

Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease (STEADFAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by vTv Therapeutics
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics
ClinicalTrials.gov Identifier:
NCT02080364
First received: February 25, 2014
Last updated: March 2, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Alzheimer's Disease
Drug: Azeliragon
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by vTv Therapeutics:

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 ]

Estimated Enrollment: 800
Study Start Date: April 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azeliragon 5mg
Azeliragon (TTP488) 5mg orally once daily for 18 months
Drug: Azeliragon
Azeliragon 5mg administered orally, once daily for 18 months
Other Name: TTP488
Placebo Comparator: Placebo
Placebo orally once daily for 18 months
Drug: Placebo
Placebo administered orally, once daily for 18 months

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080364

Contacts
Contact: Aaron H Burstein, PharmD (336) 888-0435 clinicaltrials@vtvtherapeutics.com

  Show 117 Study Locations
Sponsors and Collaborators
vTv Therapeutics
Investigators
Study Director: Aaron H Burstein, PharmD vTv Therapeutics
  More Information

Additional Information:
Responsible Party: vTv Therapeutics
ClinicalTrials.gov Identifier: NCT02080364     History of Changes
Other Study ID Numbers: TTP488-301
Study First Received: February 25, 2014
Last Updated: March 2, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by vTv Therapeutics:
Alzheimer's disease
RAGE
ADAS-cog
CDR-sb

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 25, 2017