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出境医 / 临床实验 / Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance (Elevage)

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

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Azeliragon Drug: Placebo Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : January 29, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Azeliragon
Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
 Drug: Azeliragon
Azeliragon 5 mg capsule administered orally, once daily
Other Name: TTP488
Placebo Comparator: Placebo
Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
 Drug: Placebo
Matching placebo capsule administered orally, once daily
Outcome Measures
Primary Outcome Measures :
  1. Part 1 : Change from Baseline in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog14) at Month 6 [ Time Frame: 6 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  2. Part 2: Change from Baseline in the ADAS-cog14 at Month 18 [ Time Frame: 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  3. Part 2: Change from Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 18 [ Time Frame: 18 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.


Secondary Outcome Measures :
  1. Part 1: Change from Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6 [ Time Frame: 6 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.

  2. Part 1: Change from Baseline in the Functional Activities Questionnaire (FAQ) at Month 6 [ Time Frame: 6 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.

  3. Part 1: Change from Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6 [ Time Frame: 6 months ]
    The A-IADL total score is calculated using an item response theory method of scoring and lower scores indicate greater functional impairment

  4. Part 1: Change from Baseline in estimated glomerular filtration rate (eGFR) at Month 6 [ Time Frame: 6 months ]
  5. Part 2: Responder status at Months 6, 12, and 18 based on the ADAS-cog14 [ Time Frame: 6, 12, 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment

  6. Part 2: Change from Baseline in FAQ score at Month 18 [ Time Frame: 18 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.

  7. Part 2: Change from Baseline in Amsterdam-IADL score at Month 18 [ Time Frame: 18 months ]
  8. Part 2: Change from Baseline in MMSE score at Month 18 [ Time Frame: 18 months ]
    MMSE scores range from 0-30 with lower scores indicating greater cognitive impairment.

  9. Part 2: Change from Baseline in eGFR at Month 18 [ Time Frame: 18 months ]
  10. Part 2: Change from Baseline in whole brain volume at Month 18 [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Proportions of subjects with treatment-emergent adverse events [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  2. Proportions of subjects with treatment-emergent abnormal clinical laboratory values [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  3. Proportions of subjects with abnormal values or changes in vital signs measures of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  4. Proportions of subjects with treatment-emergent 12-lead ECG results of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  5. Part 2: Change from Baseline at Month 18 for Neuropsychiatric Inventory [ Time Frame: 18 months ]
    Scores range from 0-144 with higher scores indicating a greater presence of neuropsychiatric symptoms.

  6. Part 2: Change from Baseline at Month 18 Dementia Quality of Life (DEMQOL-proxy) [ Time Frame: 18 months ]
    Higher scores indicate better health related quality of life.

  7. Part 2: Change from Baseline in plasma concentrations of Aβ species at Month 18 [ Time Frame: 18 months ]
  8. Part 2: Change from Baseline in brain MRI (hippocampal, ventricular) volumetric measures at Month 18 [ Time Frame: 18 months ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations

Locations
Show Show 33 study locations
Sponsors and Collaborators
vTv Therapeutics
Tracking Information
First Submitted Date  ICMJE May 31, 2019
First Posted Date  ICMJE June 10, 2019
Last Update Posted Date May 13, 2021
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Part 1 : Change from Baseline in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog14) at Month 6 [ Time Frame: 6 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
  • Part 2: Change from Baseline in the ADAS-cog14 at Month 18 [ Time Frame: 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
  • Part 2: Change from Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 18 [ Time Frame: 18 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Part 1: Change from Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6 [ Time Frame: 6 months ]
    Sum of box scores range from 0 to 18 with higher scores indicating greater cognitive impairment.
  • Part 1: Change from Baseline in the Functional Activities Questionnaire (FAQ) at Month 6 [ Time Frame: 6 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
  • Part 1: Change from Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6 [ Time Frame: 6 months ]
    The A-IADL total score is calculated using an item response theory method of scoring and lower scores indicate greater functional impairment
  • Part 1: Change from Baseline in estimated glomerular filtration rate (eGFR) at Month 6 [ Time Frame: 6 months ]
  • Part 2: Responder status at Months 6, 12, and 18 based on the ADAS-cog14 [ Time Frame: 6, 12, 18 months ]
    The ADAS-cog14 scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment
  • Part 2: Change from Baseline in FAQ score at Month 18 [ Time Frame: 18 months ]
    The total FAQ score ranges from 0 to 30, with higher scores indicating greater functional loss.
  • Part 2: Change from Baseline in Amsterdam-IADL score at Month 18 [ Time Frame: 18 months ]
  • Part 2: Change from Baseline in MMSE score at Month 18 [ Time Frame: 18 months ]
    MMSE scores range from 0-30 with lower scores indicating greater cognitive impairment.
  • Part 2: Change from Baseline in eGFR at Month 18 [ Time Frame: 18 months ]
  • Part 2: Change from Baseline in whole brain volume at Month 18 [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 6, 2019)
  • Proportions of subjects with treatment-emergent adverse events [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  • Proportions of subjects with treatment-emergent abnormal clinical laboratory values [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  • Proportions of subjects with abnormal values or changes in vital signs measures of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  • Proportions of subjects with treatment-emergent 12-lead ECG results of potential clinical concern [ Time Frame: 3,6 months (Part 1) ; 3,6,9,12,15,18 months (Part 2) ]
  • Part 2: Change from Baseline at Month 18 for Neuropsychiatric Inventory [ Time Frame: 18 months ]
    Scores range from 0-144 with higher scores indicating a greater presence of neuropsychiatric symptoms.
  • Part 2: Change from Baseline at Month 18 Dementia Quality of Life (DEMQOL-proxy) [ Time Frame: 18 months ]
    Higher scores indicate better health related quality of life.
  • Part 2: Change from Baseline in plasma concentrations of Aβ species at Month 18 [ Time Frame: 18 months ]
  • Part 2: Change from Baseline in brain MRI (hippocampal, ventricular) volumetric measures at Month 18 [ Time Frame: 18 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance
Official Title  ICMJE 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
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Azeliragon
    Azeliragon 5 mg capsule administered orally, once daily
    Other Name: TTP488
  • Drug: Placebo
    Matching placebo capsule administered orally, once daily
Study Arms  ICMJE
  • Experimental: Azeliragon
    Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
    Intervention: Drug: Azeliragon
  • Placebo Comparator: Placebo
    Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2)
    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: December 16, 2020) 		43
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		300
Actual Study Completion Date  ICMJE January 29, 2021
Actual Primary Completion Date December 1, 2020   (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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03980730
Other Study ID Numbers  ICMJE TTP488-305
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
Plan to Share IPD: No
Responsible Party vTv Therapeutics
Study Sponsor  ICMJE vTv Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account vTv Therapeutics
Verification Date May 2021

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

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