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for business reasons
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azeliragon | Experimental | Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) |
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| Placebo | Placebo Comparator | Matching placebo capsule administered orally, once daily for 6 months (Part 1) or 18 months (Part 2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azeliragon | Drug | Azeliragon 5 mg capsule administered orally, once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Count and Percentage of Subjects With Treatment-emergent Adverse Events | Baseline to Month 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Neuroscience Research | Tucson | Arizona | 85710 | United States | ||
| Institute for Neurodegenerative Disorders |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azeliragon | Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) Azeliragon: Azeliragon 5 mg capsule administered orally, once daily |
| FG001 | Placebo | Matching placebo capsule administered orally, once daily for 6 months (Part 1) Placebo: Matching placebo capsule administered orally, once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 29, 2019 | Nov 16, 2021 |
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| Placebo | Drug | Matching placebo capsule administered orally, once daily |
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| 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 |
| 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 |
| 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 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Brain Matters Research | Delray Beach | Florida | 33445 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Charter Research | Lady Lake | Florida | 32159 | United States |
| Alzheimer's Research and Treatment Center | Lake Worth | Florida | 33449 | United States |
| ClinCloud | Maitland | Florida | 32751 | United States |
| Synexus Clinical Research US | Orlando | Florida | 32806 | United States |
| Emerald Coast Center for Neurological Disorders | Pensacola | Florida | 32514 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| The Roskamp Institute | Sarasota | Florida | 34243 | United States |
| Brain Matters Research | Stuart | Florida | 34997 | United States |
| Emory Alzheimer's Clinical Research Unit | Atlanta | Georgia | 30329 | United States |
| NeuroStudies.net LLC | Decatur | Georgia | 30033 | United States |
| IU Health Partners, Adult Neurology Clinic | Indianapolis | Indiana | 46202 | United States |
| Memory Center / Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Millennium Psychiatric Associates | St Louis | Missouri | 63132 | United States |
| The Cognitive and Research Center of New Jersey | Springfield | New Jersey | 07081 | United States |
| Clarity Clinical Research | East Syracuse | New York | 13057 | United States |
| Neurological Associates of Long Island | Lake Success | New York | 11042 | United States |
| ANI Neurology dba Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Center for Cognitive Health | Portland | Oregon | 97225 | United States |
| Okanagan Clinical Trials Ltd. | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| True North Clinical Research Inc. | Halifax | Nova Scotia | B3S 1M7 | Canada |
| True North Clinical Research Inc. | Kentville | Nova Scotia | B4N 4K9 | Canada |
| Recherches Neuro-Hippocampe | Ottawa | Ontario | K1Z IG3 | Canada |
| Recherches Neuro-Hippocampe Inc. | Gatineau | Quebec | J8T 8J1 | Canada |
| Q&T Research Sherbrooke Inc | Sherbrooke | Quebec | J1J 2G2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azeliragon | Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) Azeliragon: Azeliragon 5 mg capsule administered orally, once daily |
| BG001 | Placebo | Matching placebo capsule administered orally, once daily for 6 months (Part 1) Placebo: Matching placebo capsule administered orally, once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Years Since Diagnosis of AD | Mean | Standard Deviation | years |
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| Education Level | Count of Participants | Participants |
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| ApoE4 Carrier Status | Count of Participants | Participants |
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| ADAS-Cog 14 Total Score | 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 | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CDR Global Score | Clinical Dementia Rating global scores are 0 for cognitively unimpaired individuals, 0.5 for questionable dementia, 1 for mild dementia, 2 for moderate dementia and 3 for severe dementia. | Count of Participants | Participants |
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| CDR Sum of Boxes | Clinical Dementia Rating - Sum of box (CDR-sb) scores range from 0 to 18 with higher scores indicating greater cognitive impairment | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| MMSE Total Score | The Mini-Mental State Exam scale range is 0 to 30 with lower scores indicating greater cognitive impairment. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | The full analysis set (FAS) includes all randomized subjects, whether or not they receive any study medication, and who have at least one post-Baseline assessment. The FAS was used for all hypothesis tests of efficacy. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Month 6 |
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| 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. | The full analysis set (FAS) includes all randomized subjects, whether or not they receive any study medication, and who have at least one post-Baseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Month 6 |
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| 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. | The full analysis set (FAS) includes all randomized subjects, whether or not they receive any study medication, and who have at least one post-Baseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Month 6 |
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| 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. | The full analysis set (FAS) includes all randomized subjects, whether or not they receive any study medication, and who have at least one post-Baseline assessment. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Month 6 |
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| 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. | Full Analysis Set | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Month 6 |
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| Other Pre-specified | Count and Percentage of Subjects With Treatment-emergent Adverse Events | The safety set (SAF) includes all subjects who receive any study medication. | Posted | Count of Participants | Participants | Baseline to Month 6 |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azeliragon | Azeliragon 5mg capsule administered orally, once daily for 6 months (Part 1) Azeliragon: Azeliragon 5 mg capsule administered orally, once daily | 0 | 21 | 1 | 21 | 9 | 21 |
| EG001 | Placebo | Matching placebo capsule administered orally, once daily for 6 months (Part 1) Placebo: Matching placebo capsule administered orally, once daily | 0 | 22 | 0 | 22 | 13 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cognitive disorder | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Non-systematic Assessment |
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Where PI requires the use of the Study Results for publication, the PI shall seek the Sponsor's written approval which shall not be unreasonably withheld; provided, however, that (i) Sponsor may require removal of any Confidential Information of Sponsor or may delay publication for a reasonable period of time in order to secure protection any IP Rights; and, (ii) as the Study is designed as a multi-center Study, no publication shall be made until after the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Clinical Operations | vTv Therapeutics LLC | 3368410300 | jfreeman@vtvtherapeutics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 8, 2020 | Nov 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000655744 | azeliragon |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other (Training, Certifications, etc.) |
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| Master's Degree |
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| High School |
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| Associate's Degree |
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| Bachelor's Degree |
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| Carrier |
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| CDR Global = 0.5 |
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