Alzheimer's DiseasePhase 1/2NCT04445831
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease
A Phase 1/2 study testing ACI-35.030 and JACI-35.054 in people with Alzheimer's Disease and Cognitive Impairment, run by AC Immune SA at 9 sites in 4 countries.
Trial summary
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Alzheimer's Disease, Cognitive Impairment, Tauopathies
- What is being tested?
- ACI-35.030 and JACI-35.054
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 31 Jul 2019to 5 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with age from 50 and up to 75 years old inclusive.
- Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria and Clinical Dementia Rating scale (CDR) global score of 0.5 or 1 respectively.
- Mini Mental State Examination (MMSE) score of 22 or above.
- Abnormal level of CSF Abeta amyloid 42 (Aß42) consistent with AD pathology at screening.
- Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor and/or memantine for at least 3 months prior to baseline.
- Subjects cared for by a reliable informant or caregiver to assure compliance, assist with clinical assessments and report safety issues.
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- Women must be post-menopausal for at least one year and/or surgically sterilized.
- Subjects who in the opinion of the investigator is able to understand and provide written informed consent.
- Both subject and informant or caregiver must be fluent in one of the languages of the study and able to comply with all study procedures, including lumbar punctures.
Who cannot join
- Participation in previous clinical trials for AD and/or for neurological disorders using active immunization unless there is documented evidence that the subject was treated with placebo only and the placebo vaccine is not expected to induce any specific immune response.
- Participation in previous clinical trials for AD and/or for neurological disorders using any passive immunization within the past 6 months (or 5 half-lives of the investigational antibody, whichever is longer) prior to screening unless there is documented evidence that the subject was treated with placebo only and the placebo is not expected to induce any specific immune response.
- Participation in previous clinical trials for AD and/or for neurological disorders using any small molecule drug including BACE-1 inhibitors within the past 3 months prior to screening.
- Concomitant participation in any other clinical trial using experimental or approved medications or therapies.
- Presence of positive Anti-nuclear Antibody (ANA) titers at a dilution of at least 1:160 in subjects without clinical symptoms of auto-immune disease.
- Current or past history of auto-immune disease, or clinical symptoms consistent with the presence of auto-immune disease.
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- Immune suppression including but not limited to the use of immunosuppressive drugs or systemic steroids unless they have been prescribed transiently more than 3 months prior to screening.
- History of severe allergic reaction (e.g., anaphylaxis) including but not limited to severe allergic reaction to previous vaccines and/or medications.
- Prior history of clinically significant hypoglycaemic episodes.
- Drug or alcohol abuse or dependence currently met or within the past five years according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.
- Any clinically significant medical condition likely to interfere with the evaluation of safety and tolerability of the study treatment and/or the adherence to the full study visit schedule.
- Any clinically significant medical condition likely to impact the immune system (e.g, any history of acquired or innate immune system disorder).
- Use of hydralazine, procainamide, quinidine, isoniazide, TNF-inhibitors, minocycline within the last 12 months prior to screening.
- Use of diltiazem unless on a stable dose for at least 3 months prior to screening.
- Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale, as the subject answering: "yes" to suicidal ideation questions 4 or 5 or answering: "yes" to suicidal behavior within the past 12 months.
- Concomitant psychiatric or neurologic disorder other than those considered to be related to AD.
- History or presence of uncontrolled seizures.
- History of meningoencephalitis within the past 10 years prior to screening.
- Subjects with a history of hemorrhagic and/or non-hemorrhagic stroke.
- Presence or history of peripheral neuropathy.
- History of inflammatory neurological disorders with potential for CNS involvement.
- Screening MRI scan showing structural evidence of alternative pathology not consistent with AD which could cause the subject's symptoms.
- MRI examination cannot be done for any reason, including but not limited to metal implants contraindicated for MRI studies and/or severe claustrophobia.
- Significant hearing or visual impairment or other issues judged relevant by the investigator preventing to comply with the protocol and to perform the outcome measures.
- Clinically significant infections or major surgical operation within 3 months prior to screening.
- Any vaccine received within the past 2 weeks before screening, including influenza vaccine.
- Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening.
- Myocardial infarction within one year prior to baseline, unstable angina pectoris, or significant coronary artery disease.
- History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in situ, or in-situ prostate cancer or in-situ breast cancer which have been fully removed and are considered cured.
- Clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, that are judged to be clinically significant in the opinion of the investigator.
- Pregnancy confirmed by blood test at screening, or subject planning to be pregnant or lactating.
- Receipt of any anticoagulant drug or antiplatelet drug, except aspirin at doses of 100 mg daily or lower.
- Receipt of any antipsychotic drugs unless on stable low doses for the treatment of insomnia.
- Donation of blood or blood products within 30 days prior to screening or plans to donate blood while participating in the study.
- Positive Venereal Disease Research Laboratory (VDRL) consistent with active syphilis at screening.
- Positive HIV test at screening.
- Laboratory or clinical evidence of active hepatitis B and/or C at screening.
- Serum creatinine greater than 1.5x upper limit of normal, abnormal thyroid function tests or clinically significant reduction in serum B12 or folate levels.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Finland3 sites
Clinical Research Services Helsinki
Helsinki
Itä-Suomen Yliopisto - Kuopion Kampus
Kuopio
Clinical Research Services Turku
Turku
Netherlands2 sites
Brain Research Center - Den Bosch
's-Hertogenbosch
Brain Research Center - Amsterdam
Amsterdam
Sweden2 sites
Minnesmottagningen - Sahlgrenska Universitetssjukhuset - Mölndal Sjukhus
Mölndal
Kognitiv Mottagning - Karolinska Universitetssjukhuset - Huddinge
Stockholm
United Kingdom2 sites
Edinburgh Clinical Research Facility
Edinburgh
University College London Hospitals NHS Foundation Trust
London
About this study
Official title: A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.
- Conditions
- Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases
- Being tested
- ACI-35.030, Placebo, JACI-35.054
- Keywords
- Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases, Central Nervous System Diseases
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Tauopathies, Dementia, Brain Diseases, Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACI-35.030Biological
Administration of a Low dose of ACI-35.030
ACI-35.030Biological
Administration of a Medium dose of ACI-35.030
ACI-35.030Biological
Administration of a High dose of ACI-35.030
PlaceboOther
Administration of Placebo
JACI-35.054Biological
Administration of a Low dose of JACI-35.054
JACI-35.054Biological
Administration of a Medium dose of JACI-35.054
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo administered at predefined time points over a 48-week period. Receives: Other: Placebo |
| ACI-35.030 - Low dose | Experimental | Active vaccine administered at predefined time points over a 48-week period. Receives: Biological: ACI-35.030 |
| ACI-35.030 - Medium dose | Experimental | Active vaccine administered at predefined time points over a 48-week period. Receives: Biological: ACI-35.030 |
| ACI-35.030 - High dose | Experimental | Active vaccine administered at predefined time points over a 48-week period. Receives: Biological: ACI-35.030 |
| JACI-35.054 - Low dose | Experimental | Active vaccine administered at predefined time points over a 48-week period. Receives: Biological: JACI-35.054 |
| JACI-35.054 - Medium dose | Experimental | Active vaccine administered at predefined time points over a 48-week period. Receives: Biological: JACI-35.054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overview of Treatment-Emergent Adverse Events, Safety Set
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Measured: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as:
- Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities.
- Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health
- Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health
Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
Measured: Between the first dosing and the last study visit (week 74)
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as:
- Unrelated: Events reported as unrelated or unlikely related to study drug
- Related: Events reported as possibly related or probably related to study drug
Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
Measured: Between the first dosing and the last study visit (week 74)
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes.
A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Measured: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes.
A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Measured: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Heart Rate, ITT Set
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes.
A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Measured: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Mean Change From Baseline in Body Temperature, ITT Set
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Measured: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
Measured: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
Number of Participants With Abnormal MRI Results, ITT Set
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
Measured: Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Measured: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Measured: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Secondary outcomes (3)
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Measured: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Measured: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
At all visits, blood was collected for the determination of the immune response in serum. Anti-Tau IgM titers were measured by enzyme-linked immunosorbent assay (ELISA). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Measured: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start31 Jul 2019
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- AC Immune SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Philip Scheltens, MD, Principal investigator, Amsterdam UMC Alzheimer Center de Boelelaan Amsterdam The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445831
- Sponsor's protocol ID
- ACI-35-1802
- Other IDs
- 2018-004573-27, 2018
- Status last verified
- Jan 2025
- First submitted
- 22 Jun 2020
- Last updated
- 14 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) are not planned to be shared for this early-phase non-pivotal ACI-35-1802 Phase 1b/2a study. However, group-level data may be shared to qualified researchers who engage in rigorous independent scientific research after the review and approval of a proposal sent to the sponsor (see Contacts) and the execution of a data sharing agreement. In addition, the Clinical Study Protocol and the Statistical Plan will be available in this registry once the study results are released.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04445831
- Acronym / sponsor ID
- ACI-35-1802
- Conditions
- Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases
- Keywords
- Alzheimer's Disease, Cognitive Impairment, Tauopathies, Mild Cognitive Impairment, Dementia, Brain Diseases, Central Nervous System Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AC Immune SAIndustry (pharma, biotech, devices)
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 24 Jun 2020 (actual)
- Results
- Posted 14 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of different doses, regimens and combinations of Tau targeted vaccines in participants with early Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered at predefined time points over a 48-week period. |
| ACI-35.030 - Low dose | Experimental | Biological: ACI-35.030Active vaccine administered at predefined time points over a 48-week period. |
| ACI-35.030 - Medium dose | Experimental | Biological: ACI-35.030Active vaccine administered at predefined time points over a 48-week period. |
| ACI-35.030 - High dose | Experimental | Biological: ACI-35.030Active vaccine administered at predefined time points over a 48-week period. |
| JACI-35.054 - Low dose | Experimental | Biological: JACI-35.054Active vaccine administered at predefined time points over a 48-week period. |
| JACI-35.054 - Medium dose | Experimental | Biological: JACI-35.054Active vaccine administered at predefined time points over a 48-week period. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female with age from 50 and up to 75 years old inclusive.
- Mild Cognitive Impairment (MCI) due to AD or Mild AD according to NIA-AA criteria and Clinical Dementia Rating scale (CDR) global score of 0.5 or 1 respectively.
- Mini Mental State Examination (MMSE) score of 22 or above.
- Abnormal level of CSF Abeta amyloid 42 (Aß42) consistent with AD pathology at screening.
- Subjects either not taking any marketed treatment for AD or receiving a stable dose of an acetylcholinesterase inhibitor and/or memantine for at least 3 months prior to baseline.
Key exclusion criteria (38 listed)
- Participation in previous clinical trials for AD and/or for neurological disorders using active immunization unless there is documented evidence that the subject was treated with placebo only and the placebo vaccine is not expected to induce any specific immune response.
- Participation in previous clinical trials for AD and/or for neurological disorders using any passive immunization within the past 6 months (or 5 half-lives of the investigational antibody, whichever is longer) prior to screening unless there is documented evidence that the subject was treated with placebo only and the placebo is not expected to induce any specific immune response.
- Participation in previous clinical trials for AD and/or for neurological disorders using any small molecule drug including BACE-1 inhibitors within the past 3 months prior to screening.
- Concomitant participation in any other clinical trial using experimental or approved medications or therapies.
- Presence of positive Anti-nuclear Antibody (ANA) titers at a dilution of at least 1:160 in subjects without clinical symptoms of auto-immune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACI-35.030Administration of a Low dose of ACI-35.030 | Biological | ACI-35.030 - Low dose |
| ACI-35.030Administration of a Medium dose of ACI-35.030 | Biological | ACI-35.030 - Medium dose |
| ACI-35.030Administration of a High dose of ACI-35.030 | Biological | ACI-35.030 - High dose |
| PlaceboAdministration of Placebo | Other | Placebo |
| JACI-35.054Administration of a Low dose of JACI-35.054 | Biological | JACI-35.054 - Low dose |
| JACI-35.054Administration of a Medium dose of JACI-35.054 | Biological | JACI-35.054 - Medium dose |
Primary outcome
Overview of Treatment-Emergent Adverse Events, Safety Set
Time frame: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)
Categorical data are presented with the number of subjects with at least one event for the defined categories. Subjects are included only once, even if they experienced multiple events in a category.
Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set
Time frame: Between the first dosing and the last study visit (week 74)
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Mild: Easily tolerated and causes minimal discomfort and does not interfere with everyday activities. * Moderate: Sufficiently discomforting to interfere with normal everyday activities; intervention may be needed. Event is not hazardous to the subject's health * Severe: Prevents normal everyday activities; treatment or other intervention usually needed. Hazard to the subject's health Although subjects may have experienced multiple events, they are included only once, in the maximum severity category
Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set
Time frame: Between the first dosing and the last study visit (week 74)
Categorical data are presented with the number of subjects with at least one Treatment-Emergent Adverse Event (TEAE) assessed as: * Unrelated: Events reported as unrelated or unlikely related to study drug * Related: Events reported as possibly related or probably related to study drug Although subjects may have experienced multiple events, they are included only once, in the strongest relationship category
Mean Change From Baseline in Diastolic Blood Pressure, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
At reported visits, diastolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Mean Change From Baseline in Systolic Blood Pressure, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
At reported visits, systolic blood pressures (mmHg = millimeter of mercury) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Mean Change From Baseline in Heart Rate, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
At reported visits, heart rates (bpm = beats per minute) were measured in sitting position only, after the subject has been sitting down for at least 5 minutes. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Mean Change From Baseline in Body Temperature, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.
At reported visits, body temperatures (°C = degree Celsius) were measured. A change from baseline value is defined as the value at post-baseline timepoint minus the baseline value, i.e. post-baseline value - baseline value
Number of Participants Reporting Suicidal Ideation or Behavior Using Columbia-Suicide Severity Rating Scale (C-SSRS), ITT Set
Time frame: Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at Visit 1 (Week 0) or Screening) to the last study visit (week 74), at weeks 26, 50 and 74.
Suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS) was assessed at Baseline (screening or visit 1 (Week 0)) and at weeks 26, 50 and 74. A set of questions related to suicidal behavior or ideation was directly asked by the rater to the subject.
Number of Participants With Abnormal MRI Results, ITT Set
Time frame: Endpoint is assessed from baseline (screening) to the last study visit (week 74), at weeks 10, 26, 50 and 74.
Brain MRI scans were conducted according to the schedule of assessments, i.e. at Baseline (screening) and at weeks 10, 26, 50, 74 and examined for evidence of brain pathology. Normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) results as interpreted by the clinical site are reported.
Anti-pTau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
At all visits, blood was collected for the determination of the immune response in serum. Anti-phosphorylated Tau (pTau) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
Anti-ePHF IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
At all visits, blood was collected for the determination of the immune response in serum. Anti-enriched paired helical filaments (ePHF) IgG titers were measured by Meso Scale Discovery (MSD). For each visit, the geometric means (AU/mL) and 95% Confidence Interval (CI) is given.
3 secondary outcomes
Anti-Tau IgG Antibody Response in Serum - Antibody Titers, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-pTau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Anti-Tau IgM Antibody Response in Serum - Antibody Titers, ITT Set
Time frame: Endpoint is assessed from baseline (i.e. mean of the titers measured at the screening and visit 1 before the first study drug administration) to the last study visit (week 74), at weeks 0, 2, 8, 10, 24, 26, 36, 48, 50, 67 and 74.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) are not planned to be shared for this early-phase non-pivotal ACI-35-1802 Phase 1b/2a study. However, group-level data may be shared to qualified researchers who engage in rigorous independent scientific research after the review and approval of a proposal sent to the sponsor (see Contacts) and the execution of a data sharing agreement. In addition, the Clinical Study Protocol and the Statistical Plan will be available in this registry once the study results are released.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Scheltens, MD principal investigator
Amsterdam UMC Alzheimer Center de Boelelaan Amsterdam The Netherlands
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ACI-35.030 and JACI-35.054 in people with Alzheimer's Disease and Cognitive Impairment, run by AC Immune SA at 9 sites in 4 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 9 inclusion and 38 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: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Finland, Netherlands, Sweden, United Kingdom. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 14 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overview of Treatment-Emergent Adverse Events, Safety Set (time frame: AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2025.