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TerminatedPhase 2Results posted

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

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

Lead sponsor

vTv Therapeutics

Asset

Azeliragon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global 0.5•MMSE 21-26•AD symptomatic therapy: stable ≥2 months

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03980730

Org study IDTTP488-305

Timeline

Milestones

Study first posted2019-06-10actual

Study start2019-06-27actual

Primary completion2020-12-01actual

Study completion2021-01-29actual

Last update posted2022-01-21actual

Results first posted2022-01-21actual

Assets

Drug assets

Azeliragon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Safety / tolerability / PK

Other (unclassified)

Global cognition

4 endpoints

Secondary/protocol endpoint

Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6

Time frame:Baseline to Month 6

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.

Time frame:Baseline to Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Part 1: Change From Baseline in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-sb) at Month 6

Time frame:Baseline to Month 6

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Azeliragonn=21 Participants	0.6	0.29
Placebon=22 Participants	1.3	0.36

Secondary/registry result

Mean Change From Baseline in the Mini Mental State Exam (MMSE) at Month 6.

Time frame:Baseline to Month 6

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Azeliragonn=21 Participants	-1.8	0.41
Placebon=22 Participants	-1.7	0.43

Function / daily living

4 endpoints

Secondary/protocol endpoint

Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6

Time frame:Baseline to Month 6

change from baseline, improvement

Secondary/protocol endpoint

Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6

Time frame:Baseline to Month 6

change from baseline, improvement

Secondary/registry result

Part 1: Change From Baseline in the Amsterdam-Instrumental Activities of Daily Living (Amsterdam-IADL) at Month 6

Time frame:Baseline to Month 6

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Azeliragonn=21 Participants	6.2	1.99
Placebon=22 Participants	9.3	2.37

Secondary/registry result

Part 1: Change From Baseline in the Functional Activities Questionnaire (FAQ) at Month 6

Time frame:Baseline to Month 6

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Azeliragonn=21 Participants	-0.5	0.84
Placebon=22 Participants	2.8	0.84

Safety / tolerability / PK

2 endpoints

Other/protocol endpoint

Count and Percentage of Subjects With Treatment-emergent Adverse Events

Time frame:Baseline to Month 6

threshold achievement, event

Other_pre_specified/registry result

Count and Percentage of Subjects With Treatment-emergent Adverse Events

Time frame:Baseline to Month 6

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
AzeliragonSubjects with at least 1 adverse eventn=21 Participants	16	-
Subjects with at least 1 serious adverse eventn=21 Participants	1	-
Subjects who had drug withdrawn due to AEn=21 Participants	2	-
PlaceboSubjects with at least 1 adverse eventn=22 Participants	16	-
Subjects with at least 1 serious adverse eventn=22 Participants	0	-
Subjects who had drug withdrawn due to AEn=22 Participants	0	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6

Time frame:Baseline to Month 6

ADAS-Cog

change from baseline, improvement

Primary/registry result/low confidence

Part 1 : Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) at Month 6

Time frame:Baseline to Month 6

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Azeliragonn=21 Participants	1.8	0.82
Placebon=22 Participants	0.4	0.69

p0.2057Mixed Models Analysis

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.