Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance

Alzheimer Disease Clinical Trial

— Elevage  

Official title:

Randomized, Double-blind, Placebo-controlled, Multicenter Studies to Evaluate the Safety and Efficacy of Azeliragon as a Treatment for Subjects With Mild Alzheimer's Disease and Impaired Glucose Tolerance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03980730
• Other study ID #: TTP488-305
• Status: Terminated
• Phase: Phase 2
• Start date: June 27, 2019
• Est. completion date: January 29, 2021

Study information

• Verified date: December 2021
• Source: vTv Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: January 29, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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
• Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
• 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 2 months prior to screening
• Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
• 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
• Previous clinical trial participation within 90 days of screening
• Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year 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 current treatment
• Women of childbearing potential
• Uncontrolled blood pressure and/or blood pressure above 140/90
• Participants receiving medications that may negatively impact cognitive function
• History of diabetic ketoacidosis within the past year
• History of chronic pancreatitis
• Stage 4 kidney disease
• Use of insulin therapy

Related Conditions & MeSH terms

• Alzheimer Disease
• Glucose Intolerance

Intervention

Drug:
• Azeliragon
Azeliragon 5 mg capsule administered orally, once daily
• Placebo
Matching placebo capsule administered orally, once daily

Locations

Country	Name	City	State
Canada	Recherches Neuro-Hippocampe Inc.	Gatineau	Quebec
Canada	True North Clinical Research Inc.	Halifax	Nova Scotia
Canada	Okanagan Clinical Trials Ltd.	Kelowna	British Columbia
Canada	True North Clinical Research Inc.	Kentville	Nova Scotia
Canada	Recherches Neuro-Hippocampe	Ottawa	Ontario
Canada	Q&T Research Sherbrooke Inc	Sherbrooke	Quebec
United States	Emory Alzheimer's Clinical Research Unit	Atlanta	Georgia
United States	JEM Research Institute	Atlantis	Florida
United States	ANI Neurology dba Alzheimer's Memory Center	Charlotte	North Carolina
United States	The Ohio State University	Columbus	Ohio
United States	NeuroStudies.net LLC	Decatur	Georgia
United States	Brain Matters Research	Delray Beach	Florida
United States	Clarity Clinical Research	East Syracuse	New York
United States	Memory Center / Hattiesburg Clinic	Hattiesburg	Mississippi
United States	IU Health Partners, Adult Neurology Clinic	Indianapolis	Indiana
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Charter Research	Lady Lake	Florida
United States	Neurological Associates of Long Island	Lake Success	New York
United States	Alzheimer's Research and Treatment Center	Lake Worth	Florida
United States	ClinCloud	Maitland	Florida
United States	Institute for Neurodegenerative Disorders	New Haven	Connecticut
United States	Synexus Clinical Research US	Orlando	Florida
United States	Emerald Coast Center for Neurological Disorders	Pensacola	Florida
United States	Progressive Medical Research	Port Orange	Florida
United States	Center for Cognitive Health	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Millennium Psychiatric Associates	Saint Louis	Missouri
United States	The Roskamp Institute	Sarasota	Florida
United States	The Cognitive and Research Center of New Jersey	Springfield	New Jersey
United States	Brain Matters Research	Stuart	Florida
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
vTv Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Count and Percentage of Subjects With Treatment-emergent Adverse Events		Baseline to Month 6
Primary	Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6	The Alzheimer's Disease Assessment Scale - Cognitive Subscale 14 Item (ADAS-cog14) scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment	Baseline to Month 6
Secondary	Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6	The Amsterdam-Instrumental Activities of Daily Living score is calculated from a questionnaire consisting of 70 items in seven categories using an item response theory method of scoring. Scores range from 20 to 80 where lower scores indicate greater functional impairment.	Baseline to Month 6
Secondary	Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6	Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment.	Baseline to Month 6
Secondary	Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6	The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.	Baseline to Month 6
Secondary	Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.	The MMSE scale range is 0 to 30 with lower scores indicating greater cognitive impairment.	Baseline to Month 6