AzTrials
AzTrials

Alzheimer Disease, Early OnsetPhase 2NCT07107074

Effects of a Widely Used Vaccine Adjuvant in Subjects With Early Alzheimer's Disease Double-blind Study to Assess the Safety and Efficacy of AD04 in Patients With Early Alzheimer's Disease - ADVANCE

A Phase 2 study testing AD04 in people with Alzheimer Disease, Early Onset, run by ADvantage Therapeutics at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this randomized, placebo-controlled phase 2b study is to prospectively evaluate AD04's potential as a disease-modifying drug in AD. By evaluating the safety, pharmacodynamics, and efficacy of AD04 in early AD patients, we aim to deliver a comprehensive and robust data set that furthers our understanding… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer Disease, Early Onset
What is being tested?
AD04
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
122 participants
Where
3 sitesin 2 countries
Study dates
8 Nov 2023to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 50-85 years old
  • Has a diagnosis of probable AD based on the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, integrating both clinical and neuropathological criteria
  • Has a Mini-Mental State Examination (MMSE) score between 22 and 30. Note: Regarding inclusion criterion #2, it is obvious that patients with an MMSE score ≥27 may not fulfill all NINCDS/ADRDA criteria, especially those referring to or requiring a state of dementia. In such cases, inclusion criteria #4 and #5 ensure the specificity of the diagnosis (prodromal stage of AD/AD-type mild cognitive impairment [MCI]).
  • Has brain MRI showing medial temporal lobe atrophy as assessed by the Scheltens' scale (score ≥2, at least at one site) or has AD-type CSF signature at a 7:3 ratio of Scheltens to CSF signature. This criterion was chosen with the goal of having a patient cohort which reflects as closely as possible that of the AFF006 study; specific cut-offs for CSF AD biomarkers will be defined based on the methodology of the selected central laboratory.
  • Has a Free and Cued Selective Reminding Test (FCSRT) total recall ≤40 or free recall ≤17, indicating hippocampal damage, episodic memory impairment, and amnestic syndrome
  • Must have results of a physical examination, including visual and auditory acuity within the acceptable range for the age group to allow neuropsychological testing
Show all 10Show fewer
  • Has Hachinski Ischemia Scale score ≤4 to distinguish AD from vascular dementia
  • Written informed consent of study-related procedures and of genetic investigations signed and dated by the patient and the caregiver
  • Availability of a partner/caregiver knowing the patient and being able to accompany the patient at the visits. He/ she will be in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the planned study visits and/or be available by telephone at designated times
  • Women of childbearing potential and men with female partners of childbearing potential must use 2 effective methods of birth control during the course of the trial and for at least 90 days after the last dose in a manner such that risk of failure is minimized. Male participants should refrain from donating sperm during the intervention period and for at least 90 days after the last dose of study intervention

Who cannot join

  • Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the Investigator
  • Any medical or neurological condition (other than AD) that might cause the participant's cognitive impairment, including:
  • History or evidence of cerebrovascular disease (stroke, transient ischemic attack, intracerebral hemorrhage), or diagnosis of possible, probable or definite vascular dementia in accordance with National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS-AIREN) criteria
  • A significant number of >4 microhemorrhages, a single prior hemorrhage > 1 cm3, >2 lacunar infarcts, a single prior infarct > 1 cm3, radiological finding supporting the NINDS-AIREN criteria as operationalized in Stroke. 2003 Aug;34(8):1907-12, meningioma with a perpendicular diameter of >1cm or significant mass effect on the brain parenchyma, evidence of a cerebral contusion, encephalomalacia, aneurysms, brain neoplasms such as gliomas or subdural hematoma/effusion with a diameter of >1cm, diffuse white matter disease (Fazekas score - deep white matter score >3) or significant mass effect on the brain parenchyma assessed by MRI at screening
  • Evidence of a clinically relevant Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis, Huntington's disease, multiple sclerosis, mental retardation, hypoxic cerebral damage, or head trauma with loss of consciousness that led to persistent cognitive deficits
  • Refractory epilepsy (has had seizures within the past 2 years)
Show all 28Show fewer
  • Has had a history within the last 5 years of a serious infectious disease affecting the brain
  • Clinically significant unstable psychiatric illness in the past 6 months
  • Has a Geriatric Depression Scale score > 6 (on the staffadministered short form)
  • Hypothyroidism or vitamin B12 deficiency (patients with corrected hypothyroidism or vitamin B12 deficiency are eligible for the study provided that treatment has been stable for 3 months before study entry)
  • Patients with long covid-19 showing long-term neurological sequelae within the past 12 months at the time of screening
  • History of chronic alcohol or drug abuse/ dependence within the past 5 years
  • Patient with past or present suicidal ideation and intent as assessed by the Columbia Suicidality Severity Rating Scale (CSSRS), or who, in the clinical judgment of the investigator, presents a serious risk of suicide
  • Presence of autoimmune disease, autoinflammatory syndrome, or immunological deficiency syndrome (including human immunodeficiency virus (HIV) infection)
  • Relevant cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the Investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
  • History within the last 2 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment; or has a life expectancy of <2 years.
  • Presence of end stage kidney failure (on dialysis) (which may affect renal clearance of aluminium)
  • Patient has hemochromatosis
  • If on conventional AD therapies such as donepezil or memantine, anticholinergics in general (including neuroleptics with anticholinergic properties, certain bladder relaxants, anticholinergic drugs for use in lung diseases), or lipid-modifying therapies, doses must be stable for at least 3 months prior to the screening visit and during the entire trial period
  • Current or anticipated use of immunosuppressive drugs such as, but not limited to, azathioprine, cyclosporine, methotrexate, tacrolimus, or mycophenylate within 2 months or any myelosuppressive or cytotoxic chemotherapies within the 12 months prior to the screening visit. Use of systemic corticosteroids equivalent to ≥20mg/week prednisone within the past 4 weeks before screening and during the course of the study (intranasal or inhaled steroids for allergies/asthma is allowed)
  • Current or anticipated use of allergy immunotherapies
  • Patient has received or plans to receive any aluminium-adjuvanted vaccines within 14 days prior to any dose of study drug
  • Pregnancy
  • Contraindication for MRI imaging, including but not limited to pacemakers; cochlear implants, cerebral aneurysm clips; implanted infusion pumps; implanted nerve stimulators; metallic splinters in the eye; other magnetic, electronic, or mechanical implants; claustrophobia; inability to lie motionless for 30 minutes; or any other clinical history or examination finding that, in the judgement of the Investigator, would pose a potential hazard in combination with MRI
  • Contraindication for CSF collection, including certain conditions and / or medications such as high doses of blood thinning agents
  • Patient has received any vaccine targeting Aβ or tau for the treatment of AD. For all other experimental AD drugs, including passive immunotherapies, participation in the active treatment phase of any AD clinical trial within 3 months (or 5 half-lives, whichever is longer), prior to Visit 1
  • Participation in the active treatment phase of any non-AD clinical trial within 30 days prior to Visit 1
  • Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the Sponsor

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Poland2 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-756

  • Promente-Centrum Neurologii i Psychogeriatrii

    Bydgoszcz, 85-133

Other trials in Poland

Austria1 site

  • Institute Neuromed

    Korneuburg, Lower Austria, 2100

Other trials in Austria

About this study

Official title: A Phase 2b, Multicenter, Randomized, Placebocontrolled, Double-blind Study to Assess the Safety and Efficacy of AD04 in Patients With Early Alzheimer's Disease - ADVANCE

The purpose of this randomized, placebo-controlled phase 2b study is to prospectively evaluate AD04's potential as a disease-modifying drug in AD. By evaluating the safety, pharmacodynamics, and efficacy of AD04 in early AD patients, we aim to deliver a comprehensive and robust data set that furthers our understanding of the effects of AD04 in AD pathology.

Being tested
AD04, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AD04Drug

    Each patient will receive 6 single s.c. injections of IMP at monthly intervals over a 5-month treatment period.

  • PlaceboDrug

    Each patient will receive 6 single s.c. injections of Placebo at monthly intervals over a 5-month treatment period.

Study groups in NCT07107074
Study groupRoleWhat they receive
1ml AD04ExperimentalEach patient will receive 6 single s.c. injections of IMP at monthly intervals over a 5-month treatment period.
Receives: Drug: AD04
1ml PBSPlacebo comparatorEach patient will receive 6 single s.c. injections of placebo at monthly intervals over a 5-month treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite score assessing cognition (aADAS-cog), daily function Activities of Daily Living (aADCS-ADL) and a global dementia severity score (CDR-sb) over 6 months measured in overall time saved with treatment

    Based on the evaluation of the time savings in cognitive, functional and global domains.

    Measured: 6 months

Secondary outcomes (3)

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: 12 months

  2. Change from baseline in Clinical Dementia Rating - sum of boxes (CDRsb)

    Measured: 12 months

  3. Change from baseline in hippocampal volume (total, right, and left), measured by volumetric Magnetic Resonance Imaging (MRI)

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start8 Nov 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07107074
Sponsor's protocol ID
ADVANCE-AD04-001
Status last verified
Jul 2025
First submitted
22 Jul 2025
Last updated
6 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AD04 in people with Alzheimer Disease, Early Onset, run by ADvantage Therapeutics at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite score assessing cognition (aADAS-cog), daily function Activities of Daily Living (aADCS-ADL) and a global dementia severity score (CDR-sb) over 6 months measured in overall time saved with treatment (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07107074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in