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TerminatedPhase 3Results posted

Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease

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

Lead sponsor

vTv Therapeutics

Asset

Azeliragon

Listed sites

115

Recruiting sites

Enrollment

880

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global 0.5•MMSE 21-26•AD symptomatic therapy: stable ≥3 months•MRI contraindications excluded

Primary endpoints

•ADAS-Cog•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

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 IDNCT02080364

Org study IDTTP488-301

Timeline

Milestones

Study first posted2014-03-06estimated

Study start2015-04actual (month precision)

Primary completion2018-06-01actual

Study completion2018-06-01actual

Last update posted2021-05-07actual

Results first posted2021-05-07actual

Assets

Drug assets

Azeliragon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 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

•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.

Endpoints (20)

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

Neuroimaging

Executive function / language

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Other (unclassified)

Global cognition

6 endpoints

Primary/protocol endpoint

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

ADAS-Cog

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

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

change from baseline, improvement

Primary/registry result

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
A-Study: Azeliragonn=138 Participants	3.8	0.51
A-Study: Placebon=151 Participants	3.1	0.49
B-Study: Azeliragonn=118 Participants	3.4	0.46
B-Study: Placebon=121 Participants	2.5	0.46

p0.3386Mixed Models Analysis

p0.1992Mixed Models Analysis

Primary/registry result

Change From Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-sb)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

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

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
A-Study: Azeliragonn=140 Participants	1.4	2.23
A-Study: Placebon=150 Participants	1.4	1.85
B-Study: Azeliragonn=117 Participants	1.3	1.87
B-Study: Placebon=120 Participants	0.7	1.4

p0.9394Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
A-Study: Azeliragonn=142 Participants	-2.1	3.55
A-Study: Placebon=153 Participants	-2.0	3.25
B-Study: Azeliragonn=121 Participants	-2.1	3.25
B-Study: Placebon=121 Participants	-1.8	3.29

Executive function / language

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Continuous Oral Word Association Task (COWAT)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Continuous Oral Word Association Task (COWAT)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Posted result

Group	Value (mean), Total acceptable Words	Standard deviation
A-Study: Azeliragonn=142 Participants	-2.0	9.61
A-Study: Placebon=153 Participants	-0.1	8.92
B-Study: Azeliragonn=180 Participants	-1.8	8.12
B-Study: Placebon=188 Participants	-0.8	8.71

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study- Activities of Daily Living Inventory (ADCS-ADL)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
A-Study: Azeliragonn=141 Participants	-5.1	8.63
A-Study: Placebon=152 Participants	-3.2	8.92
B-Study: Azeliragonn=121 Participants	-5.4	8.85
B-Study: Placebon=122 Participants	-2.8	7.83

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
A-Study: Azeliragonn=142 Participants	-0.2	9.77
A-Study: Placebon=152 Participants	1.3	11.53
B-Study: Azeliragonn=121 Participants	2.3	11.24
B-Study: Placebon=122 Participants	0.0	10.67

Neuroimaging

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures

Time frame:Baseline and 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in the Normalized Mean Composite SUVR of the 5 Regions

Time frame:Baseline to 18 months

change from baseline, improvement

Secondary/registry result

Change From Baseline in Magnetic Resonance Imaging (MRI) Brain Volumetric Measures

Time frame:Baseline and 18 months

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of Total Hippocampus Atrophy	Standard error
Azeliragon 5mgn=112 Participants	-0.016	0.001
Placebon=116 Participants	-0.014	0.001

Secondary/registry result

Change From Baseline in the Normalized Mean Composite SUVR of the 5 Regions

Time frame:Baseline to 18 months

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), SUVR ratio	Standard error
Azeliragon 5mgn=38 Participants	-0.0304	0.0039
Placebon=36 Participants	-0.0342	0.0039

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Dementia Quality of Life (DEMQOL)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Dementia Quality of Life (DEMQOL)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
A-Study: Azeliragonn=142 Participants	0.0	10.2
A-Study: Placebon=152 Participants	-1.2	9.38
B-Study: Azeliragonn=179 Participants	-0.1	10.55
B-Study: Placebon=187 Participants	-0.8	11.70

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change From Baseline in Category Fluency Test (CFT)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Secondary/registry result/low confidence

Change From Baseline in Category Fluency Test (CFT)

Time frame:Baseline and 18 months (A-Study); baseline and 12 months (B-Study)

change from baseline, improvement

Posted result

Group	Value (mean), Total Acceptable Words	Standard deviation
A-Study: Azeliragonn=142 Participants	-1.7	4.45
A-Study: Placebon=152 Participants	-1.3	4.26
B-Study: Azeliragonn=180 Participants	-1.5	3.80
B-Study: Placebon=188 Participants	9.7	146.20

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.