Trial · NCT04592874

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

NCT04592874, Phase 2, Completed, Alector Inc.; results first posted 2025-10-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease. Trials, record NCT04592874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04592874

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase 2 Study to Evaluate Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease
NCT number: NCT04592874
Status: Completed
Phases: Phase 2
Enrollment: 356 participants, actual
Lead sponsor: Alector Inc.
Conditions: Alzheimer Disease
Interventions: AL002, Placebo
First posted: 2020-10-19
Last updated: 2025-10-29
Results first posted: 2025-10-29

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Study completion up to 96 weeks	Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) score at Weeks 24, 48, 72 and 96. The CDR-SB is a tool used to measure disease severity in Alzheimer's disease. This scale assesses three domains of cognition and three domains of function. The domains are rated on a 5 point scale in which the higher the score corresponds to greater cognitive impairment. The scale range is from 0 to 18 where 0 is considered normal and 18 indicates severe dementia.
Secondary	Change in Mini-Mental Status Examination (MMSE) Score	Study completion up to 96 weeks	Change from baseline in Mini-Mental Status Examination (MMSE) score at Weeks 24, 48, 72, and 96 The MMSE is a test that assesses orientation, registration, attention and calculation, recent memory, language and constructional praxis. There is a total possible score of 30 with a lower score correlating to a higher cognitive impairment. A score of 24 to 30 is considered normal or no cognitive impairment. A score of 18 to 24 indicates mild impairment. A score of 0 to 17 indicates a severe impairment.
Secondary	Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score	Study completion up to 96 weeks	Change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score at Weeks 24, 48, 72 and 96 The RBANS test is a collection of 12 subsets representing 5 neurological domains: immediate memory, visuospatial/constructional, language, attention, and delayed memory. The scores are converted to a scale that can range from 40 to 160. The lower the score the greater the cognitive impairment.
Secondary	Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at Weeks 24, 48, 72, and 96 The ADAS-Cog13 is a scale that includes 13 items to assess cognitive function. These domains include memory, language, praxis, and orientation, as well as a number cancellation task and a delayed free recall task. There is a total score range of 0 to 85. A higher score on this scale indicates greater cognitive impairment. There are currently no universally accepted severity bands for ADAS-Cog13 as it is used to track changes in disease and not for severity.
Secondary	Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) score at Weeks 24, 48, 72, and 96 The ADCS-ADL-MCI is a scale for participants with mild cognitive impairment that observes their performance in completing activities associated with daily living. This scale is a multiple choice questionnaire and has a range of 0 to 53. A lower score on this scale indicates greater cognitive impairment.
Secondary	Change in Alzheimer's Disease Composite Score (ADCOMS) Score	Study completion up to 96 weeks	Change from baseline in Alzheimer's Disease Composite Score (ADCOMS) score at Weeks 24, 48, 72, and 96 The ADCOMS scale is a composite score of 12 components that include 4 items from the ADAS-Cog13, 2 items from the MMSE, and all 6 items from the CDR-SB scales. The range of the ADCOMS is between 0 and 1.97. The higher the score the greater the cognitive impairment.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Mini-Mental Status Examination (MMSE) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild Cognitive Impairment (ADCS-ADL-MCI) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change in Alzheimer's Disease Composite Score (ADCOMS) Score	Study completion up to 96 weeks	Adult participants with early Alzheimer's Disease excluding apolipoprotein E homozygotes	Score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group96

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 1: 15 mg/kg	Week 24 Change from Baseline	1.02	Standard Error 0.197	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 2: 40 mg/kg	Week 24 Change from Baseline	0.80	Standard Error 0.190	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 3: 60 mg/kg	Week 24 Change from Baseline	1.07	Standard Error 0.196	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Placebo	Week 24 Change from Baseline	1.15	Standard Error 0.180	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 1: 15 mg/kg	Week 48 Change from Baseline	1.68	Standard Error 0.256	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 2: 40 mg/kg	Week 48 Change from Baseline	1.61	Standard Error 0.256	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 3: 60 mg/kg	Week 48 Change from Baseline	1.95	Standard Error 0.259	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	Placebo	Week 48 Change from Baseline	1.68	Standard Error 0.236	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 1: 15 mg/kg	Week 72 Change from Baseline	2.61	Standard Error 0.366	Score on a scale
Disease Progression as Measured by the Clinical Dementia Rating - Sum of Boxes (CDR-SB) Score	AL002 Dose 2: 40 mg/kg	Week 72 Change from Baseline	2.93	Standard Error 0.358	Score on a scale

1 to 10 of 96Source ClinicalTrials.gov

See all 96 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AL002 Dose 1: 15 mg/kg	97
Overall Study	STARTED	AL002 Dose 2: 40 mg/kg	94
Overall Study	STARTED	AL002 Dose 3: 60 mg/kg	77
Overall Study	STARTED	Placebo	88
Overall Study	COMPLETED	AL002 Dose 1: 15 mg/kg	51
Overall Study	COMPLETED	AL002 Dose 2: 40 mg/kg	53
Overall Study	COMPLETED	AL002 Dose 3: 60 mg/kg	50
Overall Study	COMPLETED	Placebo	72
Overall Study	NOT COMPLETED	AL002 Dose 1: 15 mg/kg	46
Overall Study	NOT COMPLETED	AL002 Dose 2: 40 mg/kg	41

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events280

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fall	Injury, poisoning and procedural complications	AL002 Dose 1: 15 mg/kg	5	97
other	Fall	Injury, poisoning and procedural complications	AL002 Dose 2: 40 mg/kg	19	94
other	Fall	Injury, poisoning and procedural complications	AL002 Dose 3: 60 mg/kg	7	77
other	Fall	Injury, poisoning and procedural complications	Placebo	11	88
other	Infusion related reaction	Injury, poisoning and procedural complications	AL002 Dose 1: 15 mg/kg	2	97
other	Infusion related reaction	Injury, poisoning and procedural complications	AL002 Dose 2: 40 mg/kg	9	94
other	Infusion related reaction	Injury, poisoning and procedural complications	AL002 Dose 3: 60 mg/kg	10	77
other	Infusion related reaction	Injury, poisoning and procedural complications	Placebo	2	88
other	Hypertension	Vascular disorders	AL002 Dose 1: 15 mg/kg	4	97
other	Hypertension	Vascular disorders	AL002 Dose 2: 40 mg/kg	6	94

1 to 10 of 280Source ClinicalTrials.gov

See all 280 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AL002 Dose 1: 15 mg/kg	1	97
Total, all-cause mortality	AL002 Dose 2: 40 mg/kg	1	94
Total, all-cause mortality	AL002 Dose 3: 60 mg/kg	1	77
Total, all-cause mortality	Placebo	1	88
Total, other adverse events	AL002 Dose 1: 15 mg/kg	66	97
Total, other adverse events	AL002 Dose 2: 40 mg/kg	75	94
Total, other adverse events	AL002 Dose 3: 60 mg/kg	59	77
Total, other adverse events	Placebo	64	88
Total, serious adverse events	AL002 Dose 1: 15 mg/kg	14	97
Total, serious adverse events	AL002 Dose 2: 40 mg/kg	12	94

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36934371	DERIVED	PubMed
39905212	DERIVED	PubMed
40145953	DERIVED	PubMed
41787076	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests3

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Cancellation Test	Secondary outcome	ConductCognition
Delayed Recall Module	Secondary outcome	ConductCognition
Free Recall Task	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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