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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02080364




Registration number
NCT02080364
Ethics application status
Date submitted
25/02/2014
Date registered
6/03/2014
Date last updated
7/05/2021

Titles & IDs
Public title
Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
TTP488-301
Universal Trial Number (UTN)
Trial acronym
STEADFAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Azeliragon
Treatment: Drugs - Placebo

Experimental: Azeliragon 5mg - Azeliragon (TTP488) 5mg orally once daily for 18 months

Placebo comparator: Placebo - Placebo orally once daily for 18 months


Treatment: Drugs: Azeliragon
Azeliragon 5mg administered orally, once daily for 18 months

Treatment: Drugs: Placebo
Placebo administered orally, once daily for 18 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score
Timepoint [1] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Primary outcome [2] 0 0
Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)
Timepoint [2] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [1] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures
Timepoint [1] 0 0
Baseline and 18 months
Secondary outcome [2] 0 0
Change From Baseline in the Normalized Mean Composite SUVR of the 5 Regions
Timepoint [2] 0 0
Baseline to 18 months
Secondary outcome [3] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL)
Timepoint [3] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [4] 0 0
Change From Baseline in Mini-Mental State Examination (MMSE)
Timepoint [4] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [5] 0 0
Change From Baseline in Neuropsychiatric Inventory (NPI)
Timepoint [5] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [6] 0 0
Change From Baseline in Dementia Quality of Life (DEMQOL)
Timepoint [6] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [7] 0 0
Change From Baseline in Continuous Oral Word Association Task (COWAT)
Timepoint [7] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcome [8] 0 0
Change From Baseline in Category Fluency Test (CFT)
Timepoint [8] 0 0
Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
Accrual to date
Final
880
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
- Southport
Recruitment hospital [2] 0 0
- Caulfield
Recruitment hospital [3] 0 0
- Geelong
Recruitment hospital [4] 0 0
- Heidelberg West
Recruitment hospital [5] 0 0
- Nedlands
Recruitment hospital [6] 0 0
- West Perth
Recruitment postcode(s) [1] 0 0
4222 - Southport
Recruitment postcode(s) [2] 0 0
3162 - Caulfield
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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United States of America
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Georgia
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Illinois
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Kansas
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United States of America
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Kentucky
Country [8] 0 0
United States of America
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Maryland
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Massachusetts
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United States of America
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Mississippi
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
State/province [29] 0 0
Quebec
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Ireland
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Cork
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Ireland
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Dublin 8
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Ireland
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Galway
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New Zealand
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Canterbury
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South Africa
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Cape Town
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South Africa
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Johannesburg
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South Africa
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St. George
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Glasgow
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London
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Manchester
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Northampton
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Oxford
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Penarth
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Preston
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Sheffield
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Southhampton
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Swindon
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United Kingdom
State/province [47] 0 0
Warrington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
vTv Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02080364
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aaron H Burstein, PharmD
Address 0 0
vTv Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02080364