ADAMANT

CompletedPhase 2

24 Months Safety and Efficacy Study of AADvac1 in Patients With Mild Alzheimer's Disease

A 24 Months Randomised, Placebo-controlled, Parallel Group, Double Blinded, Multi Centre, Phase 2 Study to Assess Safety and Efficacy of AADvac1 Applied to Patients With Mild Alzheimer's Disease

Lead sponsor

Axon Neuroscience SE

Asset

AADvac1

Listed sites

Recruiting sites

Enrollment

208

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (CSF)•Tau biomarker required (CSF)•MMSE 20-26•MRI contraindications excluded

Primary endpoint

•Safety

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 number2015-000630-30

Org study IDAC-AD-003

NCT IDNCT02579252

Timeline

Milestones

Study first posted2015-10-19estimated

Study start2016-03 (month precision)

Primary completion2019-06actual (month precision)

Study completion2019-06actual (month precision)

Last update posted2019-11-14actual

Assets

Drug assets

AADvac1

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

(abbreviated):

•Diagnosis of probable Alzheimer's disease according to the revised National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (McKhann 2011).

•Mini Mental State Examination (MMSE) score ≥ 20 and ≤ 26.

•Brain MRI finding consistent with the diagnosis of Alzheimer's disease

•Medial temporal lobe atrophy: Scheltens score of ≥ 2 (on a scale of 0-4 on the more atrophied side) AND/OR positive AD biomarker profile in the CSF (amyloid+, tau+)

•At least 6 years of formal elementary education.

•Age 50-85 years.

•Fluency in the local language and sufficient auditory and visual capacities to allow neuropsychological testing.

•Ability to read and understand the informed consent.

•Stable therapy with an acetylcholinesterase inhibitor for at least 3 months prior to screening.

•If the patient is on memantine treatment, the dose regimen must be stable for at least 3 months prior to screening.

•Hachinski Ischemia Scale score ≤ 4.

•Availability of a caregiver.

•Female patients must be either surgically sterile or at least 2 years postmenopausal.

•Male patients must either be surgically sterile, or he and his female spouse/partner who is of childbearing potential must be using highly effective contraception starting at screening and continuing throughout the study period.

•Patient provides written informed consent

Exclusion criteria

(abbreviated):

•Participation in another clinical study within 3 months prior to screening.

•Pregnant or breastfeeding female.

•Not expected to complete the clinical study.

•Known allergy to components of the vaccine.

•Contraindication for MRI imaging.

•Any of the following detected by brain MRI:

-Infarction in the territory of large vessels

-More than one lacunar infarct.

-Any lacunar infarct in a strategically important location.

-Confluent hemispheric deep white matter lesions (Fazekas grade 3).

-Other focal lesions which may be responsible for the cognitive status of the patient or any other abnormalities associated with significant central nervous disease other than Alzheimer's disease.

•Surgery (under general anaesthesia) within 3 months prior to screening and/or scheduled surgery (under general anaesthesia) during the whole study period.

•Patient has a history and/or currently suffers from a clinically significant autoimmune disease, or is expected to receive immunosuppressive or immunomodulatory treatment at the present or in the future.

•Recent history of cancer (last specific treatment ≤ 5 years prior to Screening).

•Myocardial infarction within 2 years prior to screening.

•Hepatitis B, C, HIV or Syphilis.

•Active infectious disease.

•Presence and/or history of immunodeficiency.

•Patient currently suffering from a clinically important systemic illness:

-poorly controlled congestive heart failure (NYHA ≥ 3)

-BMI > 40

-poorly controlled diabetes (HbA1c > 7.5%)

-severe renal insufficiency (eGFR < 30 mL/min)

-chronic liver disease - ALT (alanine aminotransferase) > 66 U/L in females or > 80 U/L in males, AST (aspartate aminotransferase) > 82 U/L

-QTc interval prolongation in ECG (> 450 ms)

-other clinically significant systemic illness, if considered relevant by the investigator

•Hypothyroidism, defined as TSH (thyroid-stimulating hormone) elevation > 5.000 mcIU/mL, and/or FT4 levels < 0.7 ng/dL. Patients with corrected hypothyroidism are eligible for the study provided that treatment has been stable for 3 months before study entry.

•Valid diagnosis of a significant psychiatric illness such as schizophrenia, any type of psychotic disorder or bipolar affective disorder.

•Current depressive episode (Geriatric Depression Scale GDS ≥ 6) or major depressive episode within the last 1 years.

•Metabolic or toxic encephalopathy or dementia due to a general medical condition.

•History of alcohol or drug abuse or dependence within the past 2 years.

•Wernicke's encephalopathy.

•History or evidence of any CNS disorder other than AD that could be the cause of dementia.

•Cerebrovascular disease (ischemic or haemorrhagic stroke), or diagnosis of possible, probable or definite vascular dementia.

•Epilepsy.

•Treatment with experimental immunotherapeutics including intravenous immunoglobulin within 3 months prior to screening.

•Treatment with experimental therapies for AD aiming at disease-modification within 3 months prior to screening.

•Patient is currently being treated or was treated in the past with any active vaccines for AD.

•Treatment with immunosuppressive drugs.

•Change in dose of previous and current medications within the last 30 days prior to Screening (V01), if considered clinically relevant by the investigator.

•Vitamin B12 deficiency (serum vitamin B12 < 191 pg/mL).

Endpoints (8)

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

Memory

Function / daily living

Fluid / digital biomarkers

Safety / tolerability / PK

Global cognition

1 endpoint

Secondary/protocol endpoint

Clinical Dementia Rating (CDR) Sum of Boxes

Time frame:24 months

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

descriptive

Memory

1 endpoint

Secondary/protocol endpoint

Custom cognitive battery (composite standard score)

Time frame:24 months

categorical status, descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

Alzheimer's Disease Cooperative Study - Activities of Daily Living questionnaire (version for Mild Cognitive Impairment) (ADCS MCI ADL)

Time frame:24 months

descriptive

Neuroimaging

3 endpoints

Primary/protocol endpoint

Safety (all-case treatment-emergent adverse events except local reactions)

Time frame:24 months

event count, event

Other/protocol endpoint

Exploratory: Fludeoxyglucose Positron Emission Tomography (FDG PET) assessment of brain metabolism (change in cerebral glucose metabolic rate expressed as Standardised Uptake Value Ratio [SUVR] change, multiple regions of interest)

Time frame:24 months

change from baseline, improvement

Other/protocol endpoint

Exploratory: MRI volumetry

Time frame:24 months

descriptive

Fluid / digital biomarkers

1 endpoint

Other/protocol endpoint

Exploratory: Cerebrospinal fluid (CSF) biomarkers

Time frame:24 months

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Immunogenicity

Time frame:24 months

descriptive

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 tableno registry results posted yet

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.