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Trial record 2 of 6 for:    ttp488

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
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 : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
vTv Therapeutics

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE March 6, 2014
Last Update Posted Date May 17, 2019
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02080364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Azeliragon
    Azeliragon 5mg administered orally, once daily for 18 months
    Other Name: TTP488
  • Drug: Placebo
    Placebo administered orally, once daily for 18 months
Study Arms  ICMJE
  • Experimental: Azeliragon 5mg
    Azeliragon (TTP488) 5mg orally once daily for 18 months
    Intervention: Drug: Azeliragon
  • Placebo Comparator: Placebo
    Placebo orally once daily for 18 months
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
880
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
800
Actual Study Completion Date  ICMJE June 1, 2018
Actual Primary Completion Date June 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Ireland,   New Zealand,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02080364
Other Study ID Numbers  ICMJE TTP488-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party vTv Therapeutics
Study Sponsor  ICMJE vTv Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Aaron H Burstein, PharmD vTv Therapeutics
PRS Account vTv Therapeutics
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP