Clinical trial NCT02080364: Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
RAGE
ADAS-cog
CDR-sb
Lead sponsor: vTv Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 880
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Secondary outcomes:
measure: Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures
timeFrame: Baseline and 18 months
measure: Change From Baseline in the Normalized Mean Composite SUVR of the 5 Regions
timeFrame: Baseline to 18 months
measure: Change From Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Neuropsychiatric Inventory (NPI)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Dementia Quality of Life (DEMQOL)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Continuous Oral Word Association Task (COWAT)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
measure: Change From Baseline in Category Fluency Test (CFT)
timeFrame: Baseline and 18 months (A-Study); baseline and 12 months (B-Study)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Bellflower
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Glendale
country: United States
state: California
city: Imperial
country: United States
state: California
city: Irvine
country: United States
state: California
city: Laguna Hills
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Orange
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: San Francisco
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state: California
city: Santa Ana
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state: California
city: Atlantis
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state: Florida
city: Brooksville
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state: Florida
city: Delray Beach
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state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lake Worth
country: United States
state: Florida
city: Leesburg
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state: Florida
city: Miami Beach
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state: Florida
city: Miami Lakes
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state: Florida
city: Miami Lakes
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city: Miami
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city: Miami
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state: Florida
city: Orlando
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city: Pensacola
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city: Sarasota
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state: Florida
city: Sunrise
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state: Florida
city: Atlanta
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state: Georgia
city: Columbus
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state: Georgia
city: Chicago
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state: Illinois
city: Fairway
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state: Kansas
city: Prairie Village
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city: Lexington
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state: Kentucky
city: Baltimore
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state: Maryland
city: Newton
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state: Massachusetts
city: Plymouth
country: United States
state: Massachusetts
city: Quincy
country: United States
state: Massachusetts
city: Hattiesburg
country: United States
state: Mississippi
city: Creve Coeur
country: United States
state: Missouri
city: Princeton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
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state: New York
city: Lake Success
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state: New York
city: New York
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state: New York
city: Staten Island
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Canton
country: United States
state: Ohio
city: Shaker Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Portland
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state: Oregon
city: Media
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: Plains
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: East Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Cordova
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Kirkland
country: United States
state: Washington
city: Richland
country: United States
state: Washington
city: Southport
country: Australia
state: Queensland
city: Caulfield
country: Australia
state: Victoria
city: Geelong
country: Australia
state: Victoria
city: Heidelberg West
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: West Perth
country: Australia
state: Western Australia
city: Calgary
country: Canada
state: Alberta
city: Medicine Hat
country: Canada
state: Alberta
city: Kentville
country: Canada
state: Nova Scotia
city: Chatham
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Gatineau
country: Canada
state: Quebec
city: Greenfield Park
country: Canada
state: Quebec
city: Cork
country: Ireland
city: Dublin 8
country: Ireland
city: Galway
country: Ireland
city: Christchurch
country: New Zealand
state: Canterbury
city: Christchurch
country: New Zealand
state: Canterbury
city: Cape Town
country: South Africa
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: St. George
country: South Africa
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Northampton
country: United Kingdom
city: Oxford
country: United Kingdom
city: Penarth
country: United Kingdom
city: Preston
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Southhampton
country: United Kingdom
city: Swindon
country: United Kingdom
city: Warrington
country: United Kingdom
Study officials:
affiliation: vTv Therapeutics
name: Aaron H Burstein, PharmD
role: STUDY_DIRECTOR
References: