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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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TTP488-301
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Universal Trial Number (UTN)
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Trial acronym
STEADFAST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score
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Assessment method [1]
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The ADAS-cog is a structured scale (approximately 40 minutes to complete) that evaluates memory, orientation, attention, reasoning, language and constructional praxis (Rosen, 1984). The ADAS-cog scoring range for the version used in this study is from 0 to 70, with higher scores indicating greater cognitive impairment.
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Timepoint [1]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Primary outcome [2]
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Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)
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Assessment method [2]
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The CDR scale is used as a global measure of dementia and is completed by a clinician in the setting of detailed knowledge of the individual patient collected from interviews with the patient and caregiver (Berg, 1988). The CDR describes 5 degrees of impairment in performance on each of 6 categories including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. CDR ratings are 0 for healthy individuals, 0.5 for questionable dementia and 1, 2 and 3 for mild, moderate and severe dementia as defined in the CDR scale. The scores for each category can also be summed and this is known as the sum of box score (CSR-SB). Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
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Timepoint [2]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [1]
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Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures
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Assessment method [1]
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Percent of Total Hippocampus Atrophy to Intracranial Volume
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Timepoint [1]
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Baseline and 18 months
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Secondary outcome [2]
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Change From Baseline in the Normalized Mean Composite SUVR of the 5 Regions
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Assessment method [2]
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Extent and severity of brain hypometabolism was assessed centrally at Baseline and Month 18. SUVR PET was designed to make use of FreeSurfer-based segmentations of the brain obtained using the 3DT1 MRI. Following the methods published by Landau and Jagust (Landau SM, Annals of Neurology 2012) and described on the ADNI website (http://adni.loni.usc.edu/methods/pet-analysis-method/), regions were defined in native patient space on the 3DT1 MRI acquired at the Baseline visit and at Month 18 visit. An SUVR measure was computed regionally over five sub-regions (anterior/posterior cingulate, temporal, parietal, frontal and hippocampal areas), normalized to activity in the cerebral white matter. These sub-regions were selected to optimize sensitivity in longitudinal studies. This outcome measure presents the change from baseline in the normalized mean composite SUVR of the 5 regions. A negative change from baseline indicates a decrease (worsening) in brain glucose metabolism/utilization.
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Timepoint [2]
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Baseline to 18 months
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Secondary outcome [3]
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Change From Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL)
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Assessment method [3]
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The ADCS-ADL is an activity of daily living inventory developed by the ADCS to assess functional performance in participants with AD (Galasko et al., 1997). Informants are queried via a structured interview format as to whether participants attempted each item in the inventory during the preceding 4 weeks, as well as their level of performance. Scores range from 0-78 with lower scores indicating greater functional impairment.
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Timepoint [3]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [4]
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Change From Baseline in Mini-Mental State Examination (MMSE)
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Assessment method [4]
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The MMSE is a brief 30-point test that is used to assess cognition (Folstein, 1975). It is commonly used to screen for dementia. In the time span of about 10 minutes, it samples various functions, including arithmetic, memory and orientation. Scores range from 0-30 with lower scores indicating greater cognitive impairment.
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Timepoint [4]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [5]
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Change From Baseline in Neuropsychiatric Inventory (NPI)
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Assessment method [5]
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The NPI is a well-validated, reliable, multi-item instrument to assess psychopathology in AD based on an interview with the caregiver (Cummings et al, 1994). It evaluates both the frequency and severity of 12 behavioral areas including delusions, hallucinations, dysphoria (depression) anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, appetite and eating changes and night-time behaviors.
Frequency assessments range from 1 (occasionally, less than once per week) to 4 (very frequently, once or more per day or continuously) as well as severity (1= mild, 2 = moderate, 3 = severe). Distress is rated by the study partner or caregiver and ranges from 0 (no distress) to 5 (very severe or extreme). The overall score and the score for each subscale are the product of severity and frequency. Scores range from 0-144 with higher scores indicating a greater presence of neuropsychiatric symptoms.
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Timepoint [5]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [6]
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Change From Baseline in Dementia Quality of Life (DEMQOL)
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Assessment method [6]
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The DEMQOL-Proxy questionnaire is a validated and reliable questionnaire that is interview administered and completed by the caregiver about the patient's health related quality of life (Smith et al, 2005). It consists of 31 items representing 5 domains (daily activities and looking after yourself, health and well-being, cognitive functioning, social relationships, and self-concept) and takes approximately 20 minutes to complete. Scores range 31-124 with higher scores indicate better health related quality of life.
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Timepoint [6]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [7]
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Change From Baseline in Continuous Oral Word Association Task (COWAT)
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Assessment method [7]
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The COWAT is a measure of verbal fluency in which the participant is asked to generate orally as many words as possible that begin with the letters "F", "A", and "S", excluding proper names and different forms of the same word. (Borkowski, 1967, Loonstra 2001) For each letter, the participant is allowed one minute to generate the words. Performance is measured by the total number of correct words produced summed across the three letters. Perseverations (i.e., repetitions of a correct word) and intrusions (i.e., words not beginning with the designated letter) are noted.
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Timepoint [7]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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Secondary outcome [8]
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Change From Baseline in Category Fluency Test (CFT)
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Assessment method [8]
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Study participants are given one minute to provide exemplars of the category 'animals'.
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Timepoint [8]
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Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
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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
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2018
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Sample size
Target
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Accrual to date
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Final
880
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Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
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Recruitment hospital [1]
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- Southport
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Recruitment hospital [2]
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- Caulfield
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Recruitment hospital [3]
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- Geelong
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Recruitment hospital [4]
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- Heidelberg West
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Recruitment hospital [5]
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- Nedlands
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Recruitment hospital [6]
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- West Perth
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Recruitment postcode(s) [1]
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4222 - Southport
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Recruitment postcode(s) [2]
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3162 - Caulfield
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3081 - Heidelberg West
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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6005 - West Perth
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Recruitment outside Australia
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Arizona
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California
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Florida
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Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
vTv Therapeutics
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Address
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02080364
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Aaron H Burstein, PharmD
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Address
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vTv Therapeutics
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02080364
Download to PDF