INVOKE-2

CompletedPhase 2Results posted

A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

Lead sponsor

Alector Inc.

Asset

AL002

Listed sites

Recruiting sites

Enrollment

356

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global 0.5-1•MMSE ≥20•Study partner/caregiver required•Current anticoagulant use excluded

Primary endpoint

•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

Org study IDAL002-2

NCT IDNCT04592874

Timeline

Milestones

Study first posted2020-10-19actual

Study start2021-01-22actual

Primary completion2024-08-19actual

Study completion2024-09-12actual

Last update posted2025-10-29actual

Results first posted2025-10-29actual

Assets

Drug assets

AL002

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 Early AD including evidence of brain amyloidosis by CSF or PET

•MMSE score ≥ 20 points, CDR Global Score of 0.5 - 1.0, and RBANS score on the DMI ≤95.

•Study partner who consents to study participation and who cares for/visits the participant at least 10 hours a week

•Written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker)

Exclusion criteria

•Dementia due to a condition other than AD including, but not limited to, FTD, Parkinson's disease, dementia with Lewy bodies, Huntington disease, or vascular dementia.

•Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.

•Current uncontrolled hypertension, diabetes mellitus or thyroid disease. Clinically significant heart disease, liver disease or kidney disease.

•History or evidence of clinically significant brain disease other than AD.

•Females who are pregnant or breastfeeding, or planning to conceive within the study period.

•Any experimental vaccine or gene therapy.

•History of unresolved cancer.

•Current use of anticoagulant medications.

•Residence in a skilled nursing facility, convalescent home, or long term care facility at screening; or requires continuous nursing care.

•Participant is positive for presence of APOE e4/e4 genotype.

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

Global cognition

10 endpoints

Primary/protocol endpoint

Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:Study completion up to 96 weeks

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

change from baseline, improvement

Primary/registry result

Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score

Time frame:Study completion up to 96 weeks

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
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=66 Participants	1.02	0.197
Week 48 Change from Baselinen=62 Participants	1.68	0.256
Week 72 Change from Baselinen=32 Participants	2.61	0.366
Week 96 Change from Baselinen=20 Participants	3.17	0.488
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=73 Participants	0.80	0.190
Week 48 Change from Baselinen=60 Participants	1.61	0.256
Week 72 Change from Baselinen=34 Participants	2.93	0.358
Week 96 Change from Baselinen=18 Participants	3.61	0.498
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=68 Participants	1.07	0.196
Week 48 Change from Baselinen=59 Participants	1.95	0.259
Week 72 Change from Baselinen=31 Participants	2.12	0.372
Week 96 Change from Baselinen=18 Participants	3.31	0.506
PlaceboWeek 24 Change from Baselinen=83 Participants	1.15	0.180
Week 48 Change from Baselinen=73 Participants	1.68	0.236
Week 72 Change from Baselinen=42 Participants	2.25	0.324
Week 96 Change from Baselinen=26 Participants	3.48	0.435

Mean Difference (Final Values)-0.1795% CI-1.49 - 1.15p0.7975Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)-0.3195% CI-1.61 - 0.98p0.6341Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.1395% CI-1.18 - 1.43p0.8489Mixed Models Analysis

This is using the Week 96 timepoint

Secondary/protocol endpoint

Change in Mini-Mental Status Examination (MMSE) Score

Time frame:Study completion up to 96 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

Time frame:Study completion up to 96 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Time frame:Study completion up to 96 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in Alzheimer's Disease Composite Score (ADCOMS) Score

Time frame:Study completion up to 96 weeks

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Change in Mini-Mental Status Examination (MMSE) Score

Time frame:Study completion up to 96 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=67 Participants	-2.70	0.396
Week 48 Change from Baselinen=63 Participants	-4.06	0.541
Week 72 Change from Baselinen=32 Participants	-5.15	0.772
Week 96 Change from Baselinen=20 Participants	-5.88	0.906
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=74 Participants	-3.03	0.381
Week 48 Change from Baselinen=62 Participants	-3.91	0.535
Week 72 Change from Baselinen=34 Participants	-5.47	0.751
Week 96 Change from Baselinen=18 Participants	-7.22	0.914
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=69 Participants	-2.78	0.393
Week 48 Change from Baselinen=59 Participants	-3.74	0.549
Week 72 Change from Baselinen=31 Participants	-4.99	0.780
Week 96 Change from Baselinen=18 Participants	-5.81	0.932
PlaceboWeek 24 Change from Baselinen=83 Participants	-2.65	0.364
Week 48 Change from Baselinen=74 Participants	-3.33	0.501
Week 72 Change from Baselinen=42 Participants	-4.89	0.692
Week 96 Change from Baselinen=26 Participants	-5.47	0.814

Mean Difference (Final Values)-0.4095% CI-2.81 - 2.01p0.7417Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)-1.7495% CI-4.16 - 0.67p0.1559Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)-0.3495% CI-2.78 - 2.11p0.7850Mixed Models Analysis

This is using the Week 96 timepoint

Secondary/registry result

Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score

Time frame:Study completion up to 96 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=62 Participants	-3.37	0.857
Week 48 Change from Baselinen=53 Participants	-7.15	0.939
Week 72 Change from Baselinen=25 Participants	-6.46	1.339
Week 96 Change from Baselinen=15 Participants	-8.12	1.915
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=70 Participants	-2.34	0.820
Week 48 Change from Baselinen=55 Participants	-6.13	0.921
Week 72 Change from Baselinen=28 Participants	-6.56	1.281
Week 96 Change from Baselinen=13 Participants	-7.23	2.011
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=60 Participants	-2.65	0.870
Week 48 Change from Baselinen=50 Participants	-5.78	0.957
Week 72 Change from Baselinen=24 Participants	-5.94	1.357
Week 96 Change from Baselinen=15 Participants	-6.56	1.936
PlaceboWeek 24 Change from Baselinen=78 Participants	-3.05	0.782
Week 48 Change from Baselinen=69 Participants	-5.05	0.844
Week 72 Change from Baselinen=36 Participants	-5.86	1.149
Week 96 Change from Baselinen=23 Participants	-7.47	1.574

Mean Difference (Final Values)-0.6595% CI-5.58 - 4.28p0.7934Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.2495% CI-4.84 - 5.32p0.9259Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.9195% CI-4.04 - 5.87p0.7147Mixed Models Analysis

This is using the Week 96 timepoint

Secondary/registry result

Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score

Time frame:Study completion up to 96 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=68 Participants	1.09	0.710
Week 48 Change from Baselinen=60 Participants	3.86	0.960
Week 72 Change from Baselinen=30 Participants	7.31	1.325
Week 96 Change from Baselinen=19 Participants	9.59	1.543
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=71 Participants	3.04	0.697
Week 48 Change from Baselinen=61 Participants	6.06	0.950
Week 72 Change from Baselinen=33 Participants	8.30	1.285
Week 96 Change from Baselinen=18 Participants	10.02	1.541
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=67 Participants	3.54	0.717
Week 48 Change from Baselinen=59 Participants	5.67	0.967
Week 72 Change from Baselinen=31 Participants	7.34	1.321
Week 96 Change from Baselinen=18 Participants	11.55	1.563
PlaceboWeek 24 Change from Baselinen=81 Participants	1.93	0.659
Week 48 Change from Baselinen=73 Participants	3.79	0.880
Week 72 Change from Baselinen=37 Participants	6.26	1.205
Week 96 Change from Baselinen=24 Participants	8.62	1.397

Mean Difference (Final Values)0.9795% CI-3.14 - 5.09p0.6403Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)1.4095% CI-2.71 - 5.51p0.5016Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)2.9495% CI-1.21 - 7.08p0.1631Mixed Models Analysis

This is using the Week 96 timepoint

Secondary/registry result

Change in Alzheimer's Disease Composite Score (ADCOMS) Score

Time frame:Study completion up to 96 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=66 Participants	0.11	0.020
Week 48 Change from Baselinen=58 Participants	0.19	0.027
Week 72 Change from Baselinen=27 Participants	0.25	0.041
Week 96 Change from Baselinen=19 Participants	0.32	0.052
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=70 Participants	0.11	0.019
Week 48 Change from Baselinen=59 Participants	0.20	0.027
Week 72 Change from Baselinen=32 Participants	0.36	0.039
Week 96 Change from Baselinen=18 Participants	0.43	0.052
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=67 Participants	0.14	0.020
Week 48 Change from Baselinen=59 Participants	0.25	0.027
Week 72 Change from Baselinen=30 Participants	0.25	0.040
Week 96 Change from Baselinen=18 Participants	0.39	0.053
PlaceboWeek 24 Change from Baselinen=81 Participants	0.13	0.018
Week 48 Change from Baselinen=72 Participants	0.20	0.024
Week 72 Change from Baselinen=37 Participants	0.26	0.036
Week 96 Change from Baselinen=24 Participants	0.35	0.047

Mean Difference (Final Values)-0.0395% CI-0.17 - 0.11p0.6458Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.0895% CI-0.06 - 0.21p0.2779Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.0495% CI-0.10 - 0.18p0.5355Mixed Models Analysis

This is using the Week 96 timepoint

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score

Time frame:Study completion up to 96 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score

Time frame:Study completion up to 96 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
AL002 Dose 1: 15 mg/kgWeek 24 Change from Baselinen=66 Participants	-1.60	0.608
Week 48 Change from Baselinen=62 Participants	-2.95	0.808
Week 72 Change from Baselinen=32 Participants	-6.41	1.183
Week 96 Change from Baselinen=20 Participants	-8.50	1.517
AL002 Dose 2: 40 mg/kgWeek 24 Change from Baselinen=70 Participants	-0.99	0.594
Week 48 Change from Baselinen=61 Participants	-3.11	0.811
Week 72 Change from Baselinen=34 Participants	-6.57	1.159
Week 96 Change from Baselinen=18 Participants	-7.80	1.549
AL002 Dose 3: 60 mg/kgWeek 24 Change from Baselinen=67 Participants	-2.45	0.607
Week 48 Change from Baselinen=58 Participants	-3.46	0.828
Week 72 Change from Baselinen=31 Participants	-6.80	1.201
Week 96 Change from Baselinen=18 Participants	-7.44	1.570
PlaceboWeek 24 Change from Baselinen=81 Participants	-0.67	0.559
Week 48 Change from Baselinen=74 Participants	-2.73	0.744
Week 72 Change from Baselinen=41 Participants	-5.36	1.063
Week 96 Change from Baselinen=25 Participants	-7.97	1.368

Mean Difference (Final Values)-0.5395% CI-4.57 - 3.51p0.7945Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.1695% CI-3.92 - 4.25p0.9371Mixed Models Analysis

This is using the Week 96 timepoint

Mean Difference (Final Values)0.5395% CI-3.58 - 4.64p0.7991Mixed Models Analysis

This is using the Week 96 timepoint

Publications (4)

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

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.