CompletedPhase 2Results posted

Safety and Immunogenicity of Repeated Doses of ABvac40 in Patients With a-MCI or Vm-AD

A Multi-center, Randomized, Double-blind, Placebo-controlled, 24 Months Study in Patients With Amnestic Mild Cognitive Impairment or Very Mild Alzheimer's Disease to Investigate the Safety, Tolerability and Immune Response of Repeated Subcutaneous Injections of ABvac40

Lead sponsor

Araclon Biotech S.L.

Asset

ABvac40

Listed sites

Recruiting sites

Enrollment

134

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•MMSE 24-30•MRI contraindications excluded

Primary endpoint

•Average Maximal Increment of Anti-Aβ40 Antibody Signal

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 IDAB1601

NCT IDNCT03461276

Timeline

Milestones

Study start2017-12-13actual

Study first posted2018-03-12actual

Primary completion2023-03-23actual

Study completion2023-03-23actual

Results first posted2025-02-03actual

Last update posted2026-05-05actual

Assets

Drug assets

ABvac40

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

A subject must meet all the following inclusion criteria:

1. Male or female between 55 and 80 years of age, both inclusive, at the time of signing informed consent.

2. The patient (or legal representative, if applicable) and a close relative/caregiver must read the subject information sheet, agree to participate in the clinical trial and sign the informed consent form (the patient and a close relative/caregiver).

3. Presence of a stable caregiver to attend the patient study visits.

4. Mini-Mental Status Examination (MMSE) score between 24 and 30 points (inclusive), according to age and education level.

5. Clinical Dementia Rating (CDR) scale scoring 0.5.

6. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score on the Delayed Memory Index (DMI) of 85 or lower.

7. The results of the patient's MRI brain scan must be concordant with the diagnosis of clinical a-MCI or vm-AD according to the following criteria: Scheltens scale, and measurement of white matter and past haemorrhages.

8. If the patient is receiving treatment for AD, must have been stable during the two months before the selection visit.

9. Treatment for concomitant diseases must be stable during the previous month before the treatment of the study.

10. Positive assessment of the candidate by the investigator for complying with the requirements and procedures of the study

Exclusion criteria

A subject meeting any of the following exclusion criteria is NOT eligible for participation in the study.

1. Known allergy to components of the vaccine or prior history of anaphylaxis, a severe allergic reaction or a history of hypersensitivity to any component of the formulation. Allergy to fish or shellfish.

2. Active infectious disease (i.e. hepatitis B, C). Positive syphilis serology.

3. History or presence of autoimmune disease, except mild eczema, rhinitis or psoriasis.

4. Presence or history of immunodeficiency (i.e. HIV).

5. Significant kidney and/or liver disease.

6. History of asthma or reactive airway disease with bronchospasm in the last 6 months, or currently on regular treatment.

7. Major uncontrolled systemic condition (e.g. diabetes, congestive heart failure, hypertension).

8. History of cancer (≤5 years since the last specific treatment). Exceptions: basocellular carcinoma.

9. Significant alterations in hematological, biochemical or urine analytical parameters, particularly those relating to levels of vitamin B12, folic acid or thyroid tests.

10. History of any other central nervous system disorder, degenerative or non-degenerative neurological or psychiatric condition that, in the investigator's opinion could be the cause of the dementia, or could explain the cognitive impairment, or that might interfere with cognitive function directly or by its treatment.

11. Geriatric Depression Scale (GDS; abbreviated version), score >5

12. Has a "yes" answer to C-SSRS suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.

13. History or signs of cerebrovascular disease (ischemic or haemorrhagic stroke, transient ischemic attack), or diagnosis of possible, probable or clear vascular dementia according to NINDS-AIREN criteria.

14. Presence on MRI of a relevant pattern of microvascular disease (Leukoaraiosis, Fazekas score ≥2 in the deep white matter scale or ≥4 in the global score) or more than one lacunar or territorial infarcts. Any other MRI finding that, in the opinion of the investigator, might be a relevant contributing cause of subject´s cognitive impairment. Presence of up to 3 microhemorrhages will be acceptable.

15. History of bleeding disorder or predisposing conditions, blood clotting or clinically significant abnormal results on coagulation profile at Screening, as determined by the Investigator.

16. Patients being treated with anticoagulants or antiaggregant therapy (aspirin at a prophylactic dose ≤ 325 mg daily or clopidogrel at a dose ≤75 mg daily are allowed) should not be recruited in the study.

17. Modified Hachinski Ischemic Scale, score higher than 4.

18. Surgery (with general anaesthetic) within the previous three months to be included in the trial or programed during the study period.

19. Treatment within 30 days prior to visit 0 with systemic corticosteroids or other immunosuppressant's.

20. Vaccination against influenza or any other vaccination within 2 months before first IMP dose.

21. Patients, who have previously been randomized in this trial.

22. Participation in another clinical trial within the previous 1 month to screening visit, or within the previous 12 months after the last dose to the screening visit in the case of subjects who participated in trials with a study drug whose intention was to modify the progression AD unless documentation of receipt of placebo is available. The patient cannot be included in the study if the experimental drug was an immunotherapeutic drug, including IVIG or a vaccine against Alzheimer's disease unless documentation of receipt of placebo is available.

23. Patients with alcohol or drug abuse or dependence.

24. Absolute (having a pacemaker or implantable defibrillator) or relative (bare metal stent or stent implanted in the last six months) contraindications to MRI examination. Feeling of claustrophobic do not let perform MRI or PET scan.

25. Patients unlikely to comply with the protocol (e.g., unable to return for follow-up visits).

26. Women of childbearing potential, pregnant or nursing.

27. Significant alterations in the EKG that are associated with an added risk for the patient.

Endpoints (70)

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

Amyloid biomarkers

Other (unclassified)

Global cognition

Behavior / neuropsychiatric

Executive function / language

Function / daily living

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

6 endpoints

Secondary/protocol endpoint

Mini Mental State Examination (MMSE) Score

Time frame:Part A (baseline, and post-baseline at Week 24A, Week 50A, Week 77A, and Week 104A)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

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

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/registry result

Mini Mental State Examination (MMSE) Score

Time frame:Part A (baseline, and post-baseline at Week 24A, Week 50A, Week 77A, and Week 104A)

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 24An=62 Participants	-2.15	0.422
Week 50An=62 Participants	-3.64	0.465
Week 77An=62 Participants	-4.58	0.628
Week 104An=62 Participants	-5.98	0.816
ABvac40 Arm Part AWeek 24An=62 Participants	-2.24	0.420
Week 50An=62 Participants	-2.65	0.460
Week 77An=62 Participants	-4.15	0.621
Week 104An=62 Participants	-4.97	0.816

p= 0.8711Mixed Models Analysis

MMRM - Week 24A

p= 0.1098Mixed Models Analysis

MMRM - Week 50A

p= 0.6179Mixed Models Analysis

MMRM - Week 77A

p= 0.3715Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

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
Placebo Arm Part AWeek 24An=62 Participants	0.75	0.152
Week 50An=62 Participants	1.41	0.222
Week 77An=62 Participants	2.12	0.328
Week 104An=62 Participants	3.21	0.463
ABvac40 Arm Part AWeek 24An=62 Participants	0.73	0.156
Week 50An=62 Participants	1.36	0.221
Week 77An=62 Participants	2.05	0.325
Week 104An=62 Participants	2.90	0.462

p= 0.8949Mixed Models Analysis

MMRM - Week 24A

p= 0.8712Mixed Models Analysis

MMRM - Week 50A

p= 0.8748Mixed Models Analysis

MMRM - Week 77A

p= 0.6402Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 24An=62 Participants	-1.30	1.009
Week 50An=62 Participants	-5.45	1.076
Week 77An=62 Participants	-4.71	1.273
Week 104An=62 Participants	-3.17	1.798
ABvac40 Arm Part AWeek 24An=62 Participants	-2.10	1.022
Week 50An=62 Participants	-5.56	1.077
Week 77An=62 Participants	-2.66	1.255
Week 104An=62 Participants	-1.33	1.793

p= 0.552Mixed Models Analysis

MMRM - Week 24A

p= 0.9371Mixed Models Analysis

MMRM - Week 50A

p= 0.2354Mixed Models Analysis

MMRM - Week 77A

p= 0.4608Mixed Models Analysis

MMRM - Week 104A

Executive function / language

2 endpoints

Secondary/protocol endpoint

Trail Making Test (TMT) Scores

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/registry result

Trail Making Test (TMT) Scores

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), seconds	Standard error
Placebo Arm Part AWeek 24A - Trail An=62 Participants	0.54	2.960
Week 50A - Trail An=62 Participants	11.34	4.186
Week 77A - Trail An=62 Participants	17.42	4.669
Week 104A - Trail An=62 Participants	20.09	7.253
Week 24A - Trail Bn=62 Participants	5.43	8.102
Week 50A - Trail Bn=62 Participants	18.83	8.503
Week 77A - Trail Bn=62 Participants	17.13	8.680
Week 104A - Trail Bn=62 Participants	20.81	10.715
ABvac40 Arm Part AWeek 24A - Trail An=62 Participants	-0.59	2.939
Week 50A - Trail An=62 Participants	3.59	4.023
Week 77A - Trail An=62 Participants	2.79	4.425
Week 104A - Trail An=62 Participants	9.24	6.967
Week 24A - Trail Bn=62 Participants	-8.47	8.464
Week 50A - Trail Bn=62 Participants	18.43	9.122
Week 77A - Trail Bn=62 Participants	2.38	9.762
Week 104A - Trail Bn=62 Participants	-4.64	11.206

p= 0.777Mixed Models Analysis

MMRM - Week 24A - Trail A

p= 0.1727Mixed Models Analysis

MMRM - Week 50A - Trail A

p= 0.0218Mixed Models Analysis

MMRM - Week 77A - Trail A

p= 0.2789Mixed Models Analysis

MMRM - Week 104A - Trail A

p= 0.2261Mixed Models Analysis

MMRM - Week 24A - Trail B

p= 0.9743Mixed Models Analysis

MMRM - Week 50A - Trail B

p= 0.2556Mixed Models Analysis

MMRM - Week 77A - Trail B

p= 0.1008Mixed Models Analysis

MMRM - Week 104A - Trail B

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

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

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 24An=62 Participants	-0.99	0.834
Week 50An=62 Participants	-4.15	1.124
Week 77An=62 Participants	-6.33	1.399
Week 104An=62 Participants	-9.87	2.002
ABvac40 Arm Part AWeek 24An=62 Participants	-2.08	0.844
Week 50An=62 Participants	-3.78	1.112
Week 77An=62 Participants	-6.54	1.380
Week 104An=62 Participants	-10.02	1.982

p= 0.3246Mixed Models Analysis

MMRM - Week 24A

p= 0.8047Mixed Models Analysis

MMRM - Week 50A

p= 0.916Mixed Models Analysis

MMRM - Week 77A

p= 0.9582Mixed Models Analysis

MMRM - Week 104A

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Columbia Suicide Severity Rating Scale

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

descriptive

Secondary/protocol endpoint

EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Overall Severity Index Score

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/registry result

Columbia Suicide Severity Rating Scale

Time frame:Part A (Week 24A, Week 50A, Week 77A, and Week 104A)

descriptive

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part AWeek 24A - suicidal ideationn=57 Participants	1	-
Week 24A - suicidal behaviorn=57 Participants	0	-
Week 50A - suicidal ideationn=56 Participants	1	-
Week 50A - suicidal behaviorn=56 Participants	0	-
Week 77A - suicidal ideationn=54 Participants	1	-
Week 77A - suicidal behaviorn=54 Participants	0	-
Week 104A - suicidal ideationn=26 Participants	0	-
Week 104A - suicidal behaviorn=26 Participants	0	-
ABvac40 Arm Part AWeek 24A - suicidal ideationn=58 Participants	1	-
Week 24A - suicidal behaviorn=58 Participants	0	-
Week 50A - suicidal ideationn=58 Participants	2	-
Week 50A - suicidal behaviorn=58 Participants	0	-
Week 77A - suicidal ideationn=56 Participants	4	-
Week 77A - suicidal behaviorn=56 Participants	0	-
Week 104A - suicidal ideationn=25 Participants	0	-
Week 104A - suicidal behaviorn=25 Participants	0	-

Secondary/registry result

EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Overall Severity Index Score

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 50An=62 Participants	-0.99	1.204
Week 104An=62 Participants	-3.06	1.740
ABvac40 Arm Part AWeek 50An=62 Participants	-2.71	1.196
Week 104An=62 Participants	-0.92	1.725

p= 0.2863Mixed Models Analysis

MMRM - Week 50A

p= 0.3703Mixed Models Analysis

MMRM - Week 104A

Amyloid biomarkers

42 endpoints

Primary/protocol endpoint

Average Maximal Increment of Anti-Aβ40 Antibody Signal (Optical Density [OD] in ELISA)

Time frame:Part A (Baseline, and post-Baseline visits at Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

descriptive

Primary/registry result

Average Maximal Increment of Anti-Aβ40 Antibody Signal (Optical Density [OD] in ELISA)

Time frame:Part A (Baseline, and post-Baseline visits at Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

descriptive

Posted result

Group	Value (mean), OD	Standard deviation
Placebo Arm Part An=60 Participants	0.12	0.21
ABvac40 Arm Part An=61 Participants	3.27	0.75

p<0.0001t-test, 1 sided

p<0.0001Wilcoxon (Mann-Whitney)

Mean Difference (Final Values)3.1595% CI2.96 - 3.34p<0.0001ANCOVA

p<0.0001t-test, 1 sided

p<0.05Mixed Models Analysis

Secondary/protocol endpoint

Level of Anti-Aβ40 Antibodies in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Anti-Aβ40 Antibodies in Plasma

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Antibody-secreting Cells

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ40 Peptides in Plasma - ABtest-IA

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ42 Peptides in Plasma - ABtest-IA

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ40 Peptides in Plasma - ABtest-MS

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ42 Peptides in Plasma - ABtest-MS

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Cortical Fibrillary Amyloid Deposition Assessed by a-PET Scans

Time frame:Part A (Week 50A and Week 104A)

Amyloid PET Centiloid

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Change in Brain Volume

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Change in Hippocampal Volume

Time frame:Part A (Week 24A, Week 50A, Week 104A)

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Change in Ventricular Volume

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

percent change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ42 Peptides in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Aβ40 Peptides in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Aβ42/Aβ40 Ratio in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of Total Tau in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Level of p-Tau 181 in CSF

Time frame:Part A (Week 50A and Week 104A)

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Secondary/protocol endpoint

Level of Neurofilament Light in CSF

Time frame:Part A (Week 50A and Week 104A)

Neurofilament light (NfL)

change from baseline, improvement

Secondary/protocol endpoint

Level of Neurogranin in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/protocol endpoint

Investigator Global Evaluation (IGE) Score

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

change from baseline, improvement

Secondary/registry result

Level of Anti-Aβ40 Antibodies in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), ng/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	0.1654	3.86502
Week 104An=62 Participants	0.2014	0.36753
ABvac40 Arm Part AWeek 50An=62 Participants	30.1826	3.90756
Week 104An=62 Participants	1.2437	0.41902

p<0.001Mixed Models Analysis

MMRM - Week 50A

p= 0.047Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Anti-Aβ40 Antibodies in Plasma

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), μg/mL	Standard error
Placebo Arm Part AWeek 2An=62 Participants	1.5580	4.22100
Week 6An=62 Participants	1.5580	4.22100
Week 10An=62 Participants	1.6172	4.24276
Week 14An=62 Participants	1.5479	4.24276
Week 18An=62 Participants	1.5789	4.30746
Week 24An=62 Participants	1.5926	4.26432
Week 40An=62 Participants	1.6027	4.33264
Week 44An=62 Participants	1.5463	4.35267
Week 50An=62 Participants	1.5993	4.35363
Week 77An=62 Participants	1.5232	4.37735
Week 104An=62 Participants	1.7400	5.57743
ABvac40 Arm Part AWeek 2An=62 Participants	1.5112	4.40221
Week 6An=62 Participants	13.7052	4.44801
Week 10An=62 Participants	44.3187	4.41509
Week 14An=62 Participants	62.1946	4.43781
Week 18An=62 Participants	69.8861	4.43781
Week 24An=62 Participants	39.9483	4.44151
Week 40An=62 Participants	14.6139	4.48526
Week 44An=62 Participants	57.5771	4.48568
Week 50An=62 Participants	33.5366	4.51418
Week 77An=62 Participants	10.8197	4.57100
Week 104An=62 Participants	10.8365	5.82224

p= 0.9936Mixed Models Analysis

MMRM - Week 2A

p= 0.0391Mixed Models Analysis

MMRM - Week 6A

p< 0.0001Mixed Models Analysis

MMRM - Week 10A

p< 0.0001Mixed Models Analysis

MMRM - Week 14A

p< 0.0001Mixed Models Analysis

MMRM - Week 18A

p< 0.0001Mixed Models Analysis

MMRM - Week 24A

p= 0.0299Mixed Models Analysis

MMRM - Week 40A

p< 0.0001Mixed Models Analysis

MMRM - Week 44A

p< 0.0001Mixed Models Analysis

MMRM - Week 50A

p= 0.1267Mixed Models Analysis

MMRM - Week 77A

p= 0.2477Mixed Models Analysis

Secondary/registry result

Level of Antibody-secreting Cells

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), SFU/0.5x10^6 PBMCs	Standard error
Placebo Arm Part AWeek 2An=62 Participants	-0.4596	0.37670
Week 6An=62 Participants	-0.1172	0.72366
Week 10An=62 Participants	0.2730	0.78308
Week 14An=62 Participants	-0.1929	1.44746
Week 18An=62 Participants	0.2480	1.02814
Week 24An=62 Participants	0.4532	0.73744
Week 40An=62 Participants	-0.5655	0.42886
Week 44An=62 Participants	-1.2538	2.45677
Week 50An=62 Participants	-0.3314	1.06961
Week 77An=62 Participants	-0.4495	0.52099
Week 104An=62 Participants	0.1758	0.41889
ABvac40 Arm Part AWeek 2An=62 Participants	0.1943	0.34478
Week 6An=62 Participants	2.3198	0.67598
Week 10An=62 Participants	4.0542	0.72897
Week 14An=62 Participants	7.5160	1.36639
Week 18An=62 Participants	6.9016	0.93531
Week 24An=62 Participants	3.6179	0.67779
Week 40An=62 Participants	1.2534	0.38540
Week 44An=62 Participants	10.1860	2.23291
Week 50An=62 Participants	4.6143	1.00245
Week 77An=62 Participants	1.8385	0.47208
Week 104An=62 Participants	0.3735	0.41451

p= 0.1956Mixed Models Analysis

MMRM - Week 2A

p= 0.0152Mixed Models Analysis

MMRM - Week 6A

p= 0.0006Mixed Models Analysis

MMRM - Week 10A

p= 0.0002Mixed Models Analysis

MMRM - Week 14A

p< 0.0001Mixed Models Analysis

MMRM - Week 18A

p= 0.0020Mixed Models Analysis

MMRM - Week 24A

p= 0.0018Mixed Models Analysis

MMRM - Week 40A

p= 0.0008Mixed Models Analysis

MMRM - Week 44A

p= 0.0010Mixed Models Analysis

MMRM - Week 50A

p= 0.0014Mixed Models Analysis

MMRM - Week 77A

p= 0.7357Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ40 Peptides in Plasma - ABtest-IA

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 2An=62 Participants	3.8381	2.15040
Week 6An=62 Participants	4.5019	2.57561
Week 10An=62 Participants	5.5195	3.38710
Week 14An=62 Participants	6.0407	4.73576
Week 18An=62 Participants	8.9690	4.67231
Week 24An=62 Participants	7.6033	4.05399
Week 40An=62 Participants	5.9903	4.72341
Week 44An=62 Participants	8.6825	5.47731
Week 50An=62 Participants	7.7553	5.58033
Week 77An=62 Participants	11.2896	5.12501
Week 104An=62 Participants	9.1909	7.62291
ABvac40 Arm Part AWeek 2An=62 Participants	4.0604	2.15734
Week 6An=62 Participants	8.9863	2.56744
Week 10An=62 Participants	-2.7073	3.37532
Week 14An=62 Participants	-9.9564	4.72351
Week 18An=62 Participants	-12.7882	4.63367
Week 24An=62 Participants	-30.0419	4.02351
Week 40An=62 Participants	-42.6835	4.64278
Week 44An=62 Participants	-36.1069	5.37898
Week 50An=62 Participants	-36.3509	5.47307
Week 77An=62 Participants	-31.1947	5.03820
Week 104An=62 Participants	-15.8591	7.65813

p= 0.9386Mixed Models Analysis

MMRM - Week 2A

p= 0.2019Mixed Models Analysis

MMRM - Week 6A

p= 0.0810Mixed Models Analysis

MMRM - Week 10A

p= 0.0171Mixed Models Analysis

MMRM - Week 14A

p= 0.0011Mixed Models Analysis

MMRM - Week 18A

p< 0.0001Mixed Models Analysis

MMRM - Week 24A

p< 0.0001Mixed Models Analysis

MMRM - Week 40A

p< 0.0001Mixed Models Analysis

MMRM - Week 44A

p< 0.0001Mixed Models Analysis

MMRM - Week 50A

p< 0.0001Mixed Models Analysis

MMRM - Week 77A

p= 0.0216Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ42 Peptides in Plasma - ABtest-IA

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 2An=62 Participants	0.6745	0.47690
Week 6An=62 Participants	1.2776	0.77358
Week 10An=62 Participants	1.2091	0.88576
Week 14An=62 Participants	1.6433	0.73975
Week 18An=62 Participants	1.9821	0.55465
Week 24An=62 Participants	2.8599	0.72452
Week 40An=62 Participants	2.0361	0.84268
Week 44An=62 Participants	1.7850	1.00896
Week 50An=62 Participants	2.6958	1.24460
Week 77An=62 Participants	2.9304	1.15392
Week 104An=62 Participants	0.8402	1.36427
ABvac40 Arm Part AWeek 2An=62 Participants	0.3868	0.47126
Week 6An=62 Participants	1.6248	0.76131
Week 10An=62 Participants	2.1331	0.87167
Week 14An=62 Participants	1.0209	0.72987
Week 18An=62 Participants	1.2815	0.54507
Week 24An=62 Participants	1.6125	0.71101
Week 40An=62 Participants	-1.2781	0.81992
Week 44An=62 Participants	-0.9785	0.98520
Week 50An=62 Participants	0.5563	1.21767
Week 77An=62 Participants	0.9045	1.13274
Week 104An=62 Participants	0.5027	1.34946

p= 0.6515Mixed Models Analysis

MMRM - Week 2A

p= 0.7447Mixed Models Analysis

MMRM - Week 6A

p= 0.4518Mixed Models Analysis

MMRM - Week 10A

p= 0.5416Mixed Models Analysis

MMRM - Week 14A

p= 0.3504Mixed Models Analysis

MMRM - Week 18A

p= 0.2109Mixed Models Analysis

MMRM - Week 24A

p= 0.0049Mixed Models Analysis

MMRM - Week 40A

p= 0.0498Mixed Models Analysis

MMRM - Week 44A

p= 0.2181Mixed Models Analysis

MMRM - Week 50A

p= 0.2087Mixed Models Analysis

MMRM - Week 77A

p= 0.8599Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ40 Peptides in Plasma - ABtest-MS

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 2An=62 Participants	15.0554	86.19364
Week 6An=62 Participants	12.9981	86.19364
Week 10An=62 Participants	10.8314	86.57079
Week 14An=62 Participants	10.1449	86.57079
Week 18An=62 Participants	10.1987	87.66045
Week 24An=62 Participants	31.0861	86.93514
Week 40An=62 Participants	-26.9761	88.54373
Week 44An=62 Participants	-28.4349	88.50690
Week 50An=62 Participants	-34.2153	88.91637
Week 77An=62 Participants	-30.9656	89.32946
Week 104An=62 Participants	-37.3585	110.48329
ABvac40 Arm Part AWeek 2An=62 Participants	7.2235	87.23687
Week 6An=62 Participants	26.8351	87.24290
Week 10An=62 Participants	123.0016	87.42725
Week 14An=62 Participants	277.9974	87.75818
Week 18An=62 Participants	397.6406	88.10607
Week 24An=62 Participants	453.1893	88.16061
Week 40An=62 Participants	377.7762	88.44661
Week 44An=62 Participants	846.1633	88.82717
Week 50An=62 Participants	628.9483	88.88059
Week 77An=62 Participants	155.5480	89.69327
Week 104An=62 Participants	85.9804	113.05734

p= 0.9469Mixed Models Analysis

MMRM - Week 2A

p= 0.9063Mixed Models Analysis

MMRM - Week 6A

p= 0.3418Mixed Models Analysis

MMRM - Week 10A

p= 0.0236Mixed Models Analysis

MMRM - Week 14A

p= 0.0012Mixed Models Analysis

MMRM - Week 18A

p= 0.0004Mixed Models Analysis

MMRM - Week 24A

p= 0.0008Mixed Models Analysis

MMRM - Week 40A

p< 0.0001Mixed Models Analysis

MMRM - Week 44A

p< 0.0001Mixed Models Analysis

MMRM - Week 50A

p= 0.1255Mixed Models Analysis

MMRM - Week 77A

p= 0.4234Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ42 Peptides in Plasma - ABtest-MS

Time frame:Part A (Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 2An=62 Participants	-0.2211	1.22162
Week 6An=62 Participants	-0.2339	1.32582
Week 10An=62 Participants	-1.1074	1.32226
Week 14An=62 Participants	0.0854	1.14369
Week 18An=62 Participants	0.5632	1.51032
Week 24An=62 Participants	-0.1341	1.37466
Week 40An=62 Participants	2.8714	1.70845
Week 44An=62 Participants	1.5116	1.51817
Week 50An=62 Participants	0.1124	1.48787
Week 77An=62 Participants	1.3886	1.61156
Week 104An=62 Participants	4.6921	2.18829
ABvac40 Arm Part AWeek 2An=62 Participants	-0.0175	1.22543
Week 6An=62 Participants	1.7627	1.32847
Week 10An=62 Participants	0.8282	1.32090
Week 14An=62 Participants	0.4418	1.15082
Week 18An=62 Participants	-0.9906	1.49756
Week 24An=62 Participants	-1.6456	1.37921
Week 40An=62 Participants	3.3146	1.68116
Week 44An=62 Participants	1.9216	1.49840
Week 50An=62 Participants	2.6909	1.46207
Week 77An=62 Participants	4.6804	1.58811
Week 104An=62 Participants	2.6075	2.19973

p= 0.9031Mixed Models Analysis

MMRM - Week 2A

p= 0.2749Mixed Models Analysis

MMRM - Week 6A

p= 0.2874Mixed Models Analysis

MMRM - Week 10A

p= 0.8191Mixed Models Analysis

MMRM - Week 14A

p= 0.4559Mixed Models Analysis

MMRM - Week 18A

p= 0.4259Mixed Models Analysis

MMRM - Week 24A

p= 0.8508Mixed Models Analysis

MMRM - Week 40A

p= 0.8443Mixed Models Analysis

MMRM - Week 44A

p= 0.2075Mixed Models Analysis

MMRM - Week 50A

p= 0.1400Mixed Models Analysis

MMRM - Week 77A

p= 0.4985Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Cortical Fibrillary Amyloid Deposition Assessed by a-PET Scans

Time frame:Part A (Week 50A and Week 104A)

Amyloid PET Centiloid

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Centiloids	Standard error
Placebo Arm Part AWeek 50An=62 Participants	1.411	1.1203
Week 104An=62 Participants	4.461	1.3841
ABvac40 Arm Part AWeek 50An=62 Participants	3.561	1.0918
Week 104An=62 Participants	1.241	1.5403

p= 0.1058Mixed Models Analysis

MMRM - Week 50A

p= 0.0922Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Percentage of Change in Brain Volume

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	Standard error
Placebo Arm Part AWeek 24An=62 Participants	-1.39	0.157
Week 50An=62 Participants	-2.05	0.175
Week 104An=62 Participants	-4.16	0.470
ABvac40 Arm Part AWeek 24An=62 Participants	-1.40	0.165
Week 50An=62 Participants	-1.75	0.187
Week 104An=62 Participants	-3.11	0.412

p= 0.9313Mixed Models Analysis

MMRM - Week 24A

p= 0.2243Mixed Models Analysis

MMRM - Week 50A

p= 0.0952Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Percentage of Change in Hippocampal Volume

Time frame:Part A (Week 24A, Week 50A, Week 104A)

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	Standard error
Placebo Arm Part AWeek 24A - leftn=62 Participants	-1.63	0.450
Week 50A - leftn=62 Participants	-4.16	0.582
Week 104A - leftn=62 Participants	-7.17	1.055
Week 24A - rightn=62 Participants	-1.37	0.442
Week 50A - rightn=62 Participants	-3.34	0.513
Week 104A - rightn=62 Participants	-6.37	1.001
ABvac40 Arm Part AWeek 24A - leftn=62 Participants	-2.17	0.449
Week 50A - leftn=62 Participants	-4.26	0.568
Week 104A - leftn=62 Participants	-8.18	0.962
Week 24A - rightn=62 Participants	-1.44	0.439
Week 50A - rightn=62 Participants	-3.23	0.506
Week 104A - rightn=62 Participants	-6.49	0.901

p= 0.3647Mixed Models Analysis

MMRM - Week 24A - left

p= 0.8962Mixed Models Analysis

MMRM - Week 50A - left

p= 0.4781Mixed Models Analysis

MMRM - Week 104A - left

p= 0.9095Mixed Models Analysis

MMRM - Week 24A - right

p= 0.8744Mixed Models Analysis

MMRM - Week 50A - right

p= 0.9307Mixed Models Analysis

MMRM - Week 104A - right

Secondary/registry result

Percentage of Change in Ventricular Volume

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

percent change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percent change	Standard error
Placebo Arm Part AWeek 24An=62 Participants	5.30	0.584
Week 50An=62 Participants	10.63	0.809
Week 104An=62 Participants	22.51	1.887
ABvac40 Arm Part AWeek 24An=62 Participants	5.94	0.573
Week 50An=62 Participants	10.21	0.819
Week 104An=62 Participants	21.26	1.848

p= 0.3982Mixed Models Analysis

MMRM - Week 24A

p= 0.7035Mixed Models Analysis

MMRM - Week 50A

p= 0.6334Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ42 Peptides in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	29.0	19.40
Week 104An=62 Participants	-15.3	22.51
ABvac40 Arm Part AWeek 50An=62 Participants	-2.0	19.79
Week 104An=62 Participants	4.0	25.82

p= 0.2193Mixed Models Analysis

MMRM - Week 50A

p= 0.5543Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Aβ40 Peptides in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	-62.3	173.57
Week 104An=62 Participants	-652.4	227.08
ABvac40 Arm Part AWeek 50An=62 Participants	-141.8	180.07
Week 104An=62 Participants	-192.5	260.67

p= 0.7324Mixed Models Analysis

MMRM - Week 50A

p= 0.1719Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Aβ42/Aβ40 Ratio in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Ratio	Standard error
Placebo Arm Part AWeek 50An=62 Participants	0.0007	0.00134
Week 104An=62 Participants	0.0018	0.00182
ABvac40 Arm Part AWeek 50An=62 Participants	0.0009	0.00129
Week 104An=62 Participants	0.0021	0.00204

p= 0.9262Mixed Models Analysis

MMRM - Week 50A

p= 0.9173Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Total Tau in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	26.2	12.08
Week 104An=62 Participants	27.6	14.25
ABvac40 Arm Part AWeek 50An=62 Participants	17.8	12.40
Week 104An=62 Participants	15.9	16.43

p= 0.9220Mixed Models Analysis

MMRM - Week 50A

p= 0.5763Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of p-Tau 181 in CSF

Time frame:Part A (Week 50A and Week 104A)

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	2.84	1.664
Week 104An=62 Participants	1.97	2.386
ABvac40 Arm Part AWeek 50An=62 Participants	3.14	1.696
Week 104An=62 Participants	0.80	2.646

p= 0.8917Mixed Models Analysis

MMRM - Week 50A

p= 0.7350Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Neurofilament Light in CSF

Time frame:Part A (Week 50A and Week 104A)

Neurofilament light (NfL)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	59.36	76.513
Week 104An=62 Participants	317.11	190.948
ABvac40 Arm Part AWeek 50An=62 Participants	181.20	78.606
Week 104An=62 Participants	276.14	216.781

p= 0.2283Mixed Models Analysis

MMRM - Week 50A

p= 0.886Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Level of Neurogranin in CSF

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), pg/mL	Standard error
Placebo Arm Part AWeek 50An=62 Participants	-4.69	8.023
Week 104An=62 Participants	-34.97	13.533
ABvac40 Arm Part AWeek 50An=62 Participants	-5.93	8.328
Week 104An=62 Participants	-31.13	15.571

p= 0.909Mixed Models Analysis

MMRM - Week 50A

p= 0.8498Mixed Models Analysis

MMRM - Week 104A

Secondary/registry result

Investigator Global Evaluation (IGE) Score

Time frame:Part A (Week 24A, Week 50A, and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 24An=62 Participants	4.02	0.075
Week 50An=62 Participants	4.26	0.101
Week 104An=62 Participants	4.55	0.180
ABvac40 Arm Part AWeek 24An=62 Participants	4.07	0.077
Week 50An=62 Participants	4.21	0.101
Week 104An=62 Participants	4.45	0.184

p= 0.6189Mixed Models Analysis

MMRM - Week 24A

p= 0.6937Mixed Models Analysis

MMRM - Week 50A

p= 0.6981Mixed Models Analysis

MMRM - Week 104A

Other/protocol endpoint

Average Maximal Increment of Anti-Aβ40 Antibody Signal (Optical Density [OD] in ELISA) - Sensitivity

Time frame:Part A (Baseline, and post-Baseline visits at Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

descriptive

Other_pre_specified/registry result

Average Maximal Increment of Anti-Aβ40 Antibody Signal (Optical Density [OD] in ELISA) - Sensitivity

Time frame:Part A (Baseline, and post-Baseline visits at Week 2A, Week 6A, Week 10A, Week 14A, Week 18A, Week 24A, Week 40A, Week 44A, Week 50A, Week 77A, and Week 104A)

descriptive

Posted result

Group	Value (mean), OD	Standard deviation
Placebo Arm Part An=45 Participants	0.10	0.13
ABvac40 Arm Part An=54 Participants	3.29	0.67

p< 0.0001t-test, 1 sided

p< 0.0001Wilcoxon (Mann-Whitney)

Mean Difference (Final Values)3.2195% CI3.02 - 3.4p< 0.0001ANCOVA

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

EuroQol 5 Dimensions 5 Levels - Visual Analogue Scale (EQ-5D-5L - VAS) Score

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Secondary/registry result

EuroQol 5 Dimensions 5 Levels - Visual Analogue Scale (EQ-5D-5L - VAS) Score

Time frame:Part A (Week 50A and Week 104A)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
Placebo Arm Part AWeek 50An=62 Participants	-4.77	2.355
Week 104An=62 Participants	-5.22	3.114
ABvac40 Arm Part AWeek 50An=62 Participants	-4.92	2.323
Week 104An=62 Participants	-1.08	3.093

p= 0.9609Mixed Models Analysis

MMRM - Week 50A

p= 0.3310Mixed Models Analysis

MMRM - Week 104A

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Subject Discontinuations Due to TEAEs

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/registry result

Subject Discontinuations Due to TEAEs

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	4	-
ABvac40 Arm Part An=64 Participants	2	-
ABvac40 Arm Part Bn=37 Participants	0	-
Placebo+Booster Arm Part Bn=40 Participants	1	-

Other (unclassified)

10 endpoints

Secondary/protocol endpoint/low confidence

Number of Subjects With Clinically Significant Abnormalities in Physical Examination

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/protocol endpoint/low confidence

Number of Subjects With Clinically Significant Abnormalities in Neurological Examination

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/protocol endpoint/low confidence

Number of Subjects With Clinically Significant Abnormalities in Analytical Hematology

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/protocol endpoint/low confidence

Number of Subjects With Clinically Significant Abnormalities in Analytical Biochemistry

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/protocol endpoint/low confidence

Number of Subjects With Clinically Significant Abnormalities in Coagulation

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Secondary/registry result/low confidence

Number of Subjects With Clinically Significant Abnormalities in Physical Examination

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	4	-
ABvac40 Arm Part An=64 Participants	1	-
ABvac40 Arm Part Bn=37 Participants	4	-
Placebo+Booster Arm Part Bn=40 Participants	2	-

Secondary/registry result/low confidence

Number of Subjects With Clinically Significant Abnormalities in Neurological Examination

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	6	-
ABvac40 Arm Part An=64 Participants	5	-
ABvac40 Arm Part Bn=37 Participants	2	-
Placebo+Booster Arm Part Bn=40 Participants	1	-

Secondary/registry result/low confidence

Number of Subjects With Clinically Significant Abnormalities in Analytical Hematology

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	5	-
ABvac40 Arm Part An=64 Participants	4	-
ABvac40 Arm Part Bn=37 Participants	0	-
Placebo+Booster Arm Part Bn=40 Participants	6	-

Secondary/registry result/low confidence

Number of Subjects With Clinically Significant Abnormalities in Analytical Biochemistry

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	12	-
ABvac40 Arm Part An=64 Participants	5	-
ABvac40 Arm Part Bn=37 Participants	6	-
Placebo+Booster Arm Part Bn=40 Participants	6	-

Secondary/registry result/low confidence

Number of Subjects With Clinically Significant Abnormalities in Coagulation

Time frame:Entire study duration (Week 0 to Week 104 in Part A, and Week 0 to Week 77 in Part B)

event count, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Placebo Arm Part An=60 Participants	4	-
ABvac40 Arm Part An=64 Participants	1	-
ABvac40 Arm Part Bn=37 Participants	3	-
Placebo+Booster Arm Part Bn=40 Participants	2	-

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

Pascual-Lucas M, Lacosta AM, Montanes M, Canudas J, Loscos J, Monleon I, Allue JA, Sarasa L, Fandos N, Romero J, Sarasa M, Torres M, Whyms D, Terencio J, Pinol-Ripoll G, Boada M. Safety, tolerability, immunogenicity, and efficacy of ABvac40 active immunotherapy against Abeta40 in patients with mild cognitive impairment or very mild Alzheimer's disease: A randomized, double-blind, placebo-controlled phase 2 study. Alzheimers Dement. 2025 Oct;21(10):e70776. doi: 10.1002/alz.70776.
PMID41058018via RESULT

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.