APOLLOE4

CompletedPhase 3Results posted

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

Lead sponsor

Alzheon Inc.

Asset

ALZ-801

Listed sites

Recruiting sites

Enrollment

325

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 22-30

Primary endpoints

•ADAS-Cog•Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)

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

Eudract number2020-005755-20

Org study IDALZ-801-AD301

NCT IDNCT04770220

NihR01AG065253

Timeline

Milestones

Study first posted2021-02-25actual

Study start2021-05-19actual

Primary completion2024-05-29actual

Study completion2024-07-29actual

Last update posted2025-11-10actual

Results first posted2025-11-10actual

Assets

Drug assets

ALZ-801

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.

•Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).

•MMSE score at Screening of 22 to 30 (inclusive).

•CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.

•RBANS delayed memory index score ≤ 85.

•Evidence of progressive memory loss over the last 12 months per investigator assessment

Exclusion criteria

•Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.

•Diagnosis of neurodegenerative disorder other than AD.

•Diagnosis of major depressive disorder (MDD) within one year prior to screening.

•Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.

•History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.

•History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years).

•Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Endpoints (71)

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

Neuroimaging

Global cognition

Function / daily living

Neurodegeneration biomarkers

Safety / tolerability / PK

Global cognition

18 endpoints

Primary/protocol endpoint

Primary Cognitive Efficacy Endpoint (ADAS-Cog13)

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Primary/registry result

Primary Cognitive Efficacy Endpoint (ADAS-Cog13)

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=158 Participants	4.40	0.69
ALZ-801n=162 Participants	3.89	0.69

Least Squares Mean Difference-0.51p0.6058MMRM

Secondary/protocol endpoint

Key Secondary Endpoint (CDR-SB)

Time frame:Baseline to Week 78

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

change from baseline, improvement

Secondary/protocol endpoint

Global Cognition Assessment (MMSE)

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Key Secondary Endpoint (CDR-SB)

Time frame:Baseline to Week 78

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
Placebon=158 Participants	1.36	0.21
ALZ-801n=162 Participants	1.05	0.22

Least Squares Mean Difference-0.31p0.3090MMRM

Secondary/registry result

Global Cognition Assessment (MMSE)

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=158 Participants	-2.03	0.33
ALZ-801n=162 Participants	-1.60	0.33

Least Squares Mean Difference0.35p0.4484MMRM

Other/protocol endpoint

Cognitive Efficacy Endpoint (ADAS-Cog 13) - MCI Subgroup

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

Cognitive Efficacy Endpoint (ADAS-Cog 13) - Mild Alzheimer's Disease(Mild AD) Subgroup

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Other/protocol endpoint

CDR-SB - MCI Subgroup

Time frame:Baseline to Week 78

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

change from baseline, improvement

Other/protocol endpoint

CDR-SB - Mild AD Subgroup

Time frame:Baseline to Week 78

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

change from baseline, improvement

Other/protocol endpoint

Global Cognition Assessment (MMSE) - MCI Subgroup

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other/protocol endpoint

Global Cognition Assessment (MMSE) - Mild AD Subgroup

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Other_pre_specified/registry result

Cognitive Efficacy Endpoint (ADAS-Cog 13) - MCI Subgroup

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=58 Participants	4.10	0.81
ALZ-801n=67 Participants	1.97	0.83

Least Squares Mean Difference-2.14p0.0416MMRM

Other_pre_specified/registry result

Cognitive Efficacy Endpoint (ADAS-Cog 13) - Mild Alzheimer's Disease(Mild AD) Subgroup

Time frame:Baseline to Week 78

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=100 Participants	4.79	0.75
ALZ-801n=95 Participants	5.66	0.75

Least Squares Mean Difference0.87p0.3945MMRM

Other_pre_specified/registry result

CDR-SB - MCI Subgroup

Time frame:Baseline to Week 78

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
Placebon=58 Participants	0.63	0.26
ALZ-801n=67 Participants	-0.02	0.27

Least Squares Mean Difference-0.646p0.0533MMRM

Other_pre_specified/registry result

CDR-SB - Mild AD Subgroup

Time frame:Baseline to Week 78

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
Placebon=100 Participants	1.84	0.23
ALZ-801n=95 Participants	1.97	0.24

Least Squares Mean Difference0.127p0.6854MMRM

Other_pre_specified/registry result

Global Cognition Assessment (MMSE) - MCI Subgroup

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Placebon=58 Participants	-1.4	0.4
ALZ-801n=67 Participants	-0.5	0.4

Least Squares Mean Difference0.995% CI-0.103 - 1.845p0.0795MMRM

Other_pre_specified/registry result

Global Cognition Assessment (MMSE) - Mild AD Subgroup

Time frame:Baseline to Week 78

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=100 Participants	-2.6	0.4
ALZ-801n=95 Participants	-2.7	0.4

Least Squares Mean Difference-0.195% CI-1.070 - 0.845p0.8169MMRM

Function / daily living

12 endpoints

Secondary/protocol endpoint

Key Secondary Endpoint (A-IADL-W)

Time frame:Baseline to Week 78

change from baseline, improvement

Secondary/protocol endpoint

Functional Assessment (DAD)

Time frame:Baseline to Week 78

change from baseline, improvement

Secondary/registry result

Key Secondary Endpoint (A-IADL-W)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=158 Participants	13.59	2.02
ALZ-801n=162 Participants	13.60	2.00

Least Squares Mean Difference0.01p0.9966MMRM

Secondary/registry result

Functional Assessment (DAD)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=158 Participants	-9.2	1.7
ALZ-801n=162 Participants	-6.5	1.7

Least Squares Mean Difference2.6p0.2763MMRM

Other/protocol endpoint

A-IADL-W - MCI Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

A-IADL-W - Mild AD Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Functional Assessment (DAD) - MCI Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Functional Assessment (DAD) - Mild AD Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Other_pre_specified/registry result

A-IADL-W - MCI Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=58 Participants	4.84	2.45
ALZ-801n=67 Participants	1.43	2.50

Least Squares Mean Difference-3.41p0.2682MMRM

Other_pre_specified/registry result

A-IADL-W - Mild AD Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=100 Participants	18.55	2.21
ALZ-801n=95 Participants	22.20	2.21

Least Squares Mean Difference3.66p0.2178MMRM

Other_pre_specified/registry result

Functional Assessment (DAD) - MCI Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=58 Participants	-6.3	1.9
ALZ-801n=67 Participants	-0.2	2.0

Least Squares Mean Difference6.10p0.0161MMRM

Other_pre_specified/registry result

Functional Assessment (DAD) - Mild AD Subgroup

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebon=100 Participants	-11.1	1.8
ALZ-801n=95 Participants	-11.6	1.8

Least Squares Mean Difference-0.51p0.8387MMRM

Neurodegeneration biomarkers

6 endpoints

Other/protocol endpoint

Imaging Biomarker Endpoint (Hippocampal Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Hippocampal Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Hippocampal Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other_pre_specified/registry result

Imaging Biomarker Endpoint (Hippocampal Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=144 Participants	-418.5	21.46
ALZ-801n=146 Participants	-345.0	22.01

Least Squares Mean Difference73.505p0.0174MMRM

Other_pre_specified/registry result

Hippocampal Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=52 Participants	-411.2	29.60
ALZ-801n=61 Participants	-303.1	30.16

Least Squares Mean Difference108.1p0.0042MMRM

Other_pre_specified/registry result

Hippocampal Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=92 Participants	-423.2	23.27
ALZ-801n=85 Participants	-371.8	24.75

Least Squares Mean Difference51.3p0.1145MMRM

Neuroimaging

33 endpoints

Other/protocol endpoint

Imaging Biomarker Endpoint (Cortical Thickness [Whole Cortex])

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint (Cortical Thickness [Mayo Index])

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint (Whole Brain Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint (Ventricular Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint - DTI in Grey Matter Mean Diffusivity - Bilateral Caudate

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint - DTI in White Matter Mean Diffusivity (Bilateral Fornix)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Imaging Biomarker Endpoint - White Matter Fractional Anisotropy (Bilateral Fornix)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Cortical Thickness (Whole Cortex) (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Cortical Thickness (Whole Cortex) (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Cortical Thickness (Mayo Index) (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Cortical Thickness (Mayo Index) (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Whole Brain Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Whole Brain Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Ventricular Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other/protocol endpoint

Ventricular Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Other_pre_specified/registry result

Imaging Biomarker Endpoint (Cortical Thickness [Whole Cortex])

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=144 Participants	-0.060	0.003
ALZ-801n=146 Participants	-0.048	0.003

Least Squares Mean Difference0.012p0.0020MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint (Cortical Thickness [Mayo Index])

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=144 Participants	-0.121	0.005
ALZ-801n=146 Participants	-0.099	0.005

Least Squares Mean Difference0.021p0.0040MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint (Whole Brain Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=144 Participants	-17877.0	955.98
ALZ-801n=146 Participants	-15056.0	979.86

Least Squares Mean Difference2821.027p0.0400MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint (Ventricular Volume)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=144 Participants	5186.3	256.19
ALZ-801n=146 Participants	4028.9	262.86

Least Squares Mean Difference-1157p0.0018MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint - DTI in Grey Matter Mean Diffusivity - Bilateral Caudate

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), square millimeters per second (mm²/s)	Standard error
Placebon=103 Participants	0.000028	0.00000775
ALZ-801n=105 Participants	0.000007439	0.00000792

Least Squares Mean Difference-0.000021495% CI-0.0000432 - 0.00000037p0.054MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint - DTI in White Matter Mean Diffusivity (Bilateral Fornix)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), square millimeters per second (mm²/s)	Standard error
Placebon=103 Participants	0.0000237	0.0000058
ALZ-801n=105 Participants	0.000000843	0.00000593

Least Squares Mean Difference-0.000022895% CI-0.0000391 - -0.0000065p0.0064MMRM

Other_pre_specified/registry result

Imaging Biomarker Endpoint - White Matter Fractional Anisotropy (Bilateral Fornix)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale (fractions 0-1)	Standard error
Placebon=103 Participants	-0.0154	0.00332
ALZ-801n=105 Participants	-0.002089	0.00336

Least Squares Mean Difference0.00945595% CI0.0001469 - 0.01876p0.0465MMRM

Other_pre_specified/registry result

Cortical Thickness (Whole Cortex) (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=52 Participants	-0.059	0.004
ALZ-801n=61 Participants	-0.038	0.004

Least Squares Mean Difference0.020p< 0.0001MMRM

Other_pre_specified/registry result

Cortical Thickness (Whole Cortex) (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=92 Participants	-0.061	0.003
ALZ-801n=85 Participants	-0.054	0.003

Least Squares Mean Difference0.007p0.0985MMRM

Other_pre_specified/registry result

Cortical Thickness (Mayo Index) (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=52 Participants	-0.117	0.007
ALZ-801n=61 Participants	-0.084	0.007

Least Squares Mean Difference0.033p0.0002MMRM

Other_pre_specified/registry result

Cortical Thickness (Mayo Index) (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mm	Standard error
Placebon=92 Participants	-0.123	0.006
ALZ-801n=85 Participants	-0.109	0.006

Least Squares Mean Difference0.014p0.0699MMRM

Other_pre_specified/registry result

Whole Brain Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=52 Participants	-17559.5	1417.91
ALZ-801n=61 Participants	-13715.7	1449.14

Least Squares Mean Difference3843.824p0.0267MMRM

Other_pre_specified/registry result

Whole Brain Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=92 Participants	-18081.4	1056.74
ALZ-801n=85 Participants	-15917.1	1143.24

Least Squares Mean Difference2164.299p0.1386MMRM

Other_pre_specified/registry result

Ventricular Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=52 Participants	4490.5	343.65
ALZ-801n=61 Participants	3178.2	350.44

Least Squares Mean Difference-1312p0.0029MMRM

Other_pre_specified/registry result

Ventricular Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=92 Participants	5630.4	274.91
ALZ-801n=85 Participants	4573.4	294.71

Least Squares Mean Difference-1057p0.0065MMRM

Post_hoc/registry result

Cerebellar Volume

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=144 Participants	-577.0	62.50
ALZ-801n=146 Participants	-427.2	64.70

Least Squares Mean Difference149.800p0.0966MMRM

Post_hoc/registry result

Cerebellar Volume (MCI Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=52 Participants	-566.8	91.78
ALZ-801n=61 Participants	-428.8	94.09

Least Squares Mean Difference137.943p0.2200MMRM

Post_hoc/registry result

Cerebellar Volume (Mild AD Subgroup)

Time frame:Baseline to Week 78

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), microliters	Standard error
Placebon=92 Participants	-583.6	68.62
ALZ-801n=85 Participants	-426.2	75.18

Least Squares Mean Difference157.414p0.1005MMRM

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)

Time frame:Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)

event count, event

Primary/registry result

Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
PlaceboTEAEn=162 Participants	137	-
Study drug related TEAEn=162 Participants	44	-
Serious TEAEn=162 Participants	13	-
Serious study drug related TEAEn=162 Participants	0	-
TEAE leading to discontinuation of study drugn=162 Participants	4	-
Study drug related TEAE leading to study drug discontinuationn=162 Participants	1	-
ALZ-801TEAEn=163 Participants	140	-
Study drug related TEAEn=163 Participants	75	-
Serious TEAEn=163 Participants	14	-
Serious study drug related TEAEn=163 Participants	1	-
TEAE leading to discontinuation of study drugn=163 Participants	13	-
Study drug related TEAE leading to study drug discontinuationn=163 Participants	10	-

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Abushakra S, Power A, Watson D, Porsteinsson A, Sabbagh M, MacSweeney E, Cohen S, Boada Rovira M, Doraiswamy PM, Liang E, Flint S, Kesslak JP, McLaine R, Albayrak A, Schaefer J, Yu J, Tolar L, Dickson S, Hey JA, Tolar M. Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEepsilon4/epsilon4 Homozygotes with Early Alzheimer's Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial. Drugs. 2025 Nov;85(11):1455-1472. doi:…
PMID41015981via DERIVED

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.