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ALTITUDE-AD

Active not recruitingPhase 2

A Study to Evaluate Efficacy and Safety of Intravenous Sabirnetug in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

A Phase 2 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Intravenous Sabirnetug in Early Alzheimer's Disease

Asset

Sabirnetug

Listed sites

68

Recruiting sites

-

Enrollment

542

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•CDR global 0.5•MMSE 22-30•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•ADAS-Cog

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

Registry2023-509807-34-00EU CT Number
Org study IDACU193-201
NCT IDNCT06335173

Timeline

Milestones

Study start2024-02-29actual
Study first posted2024-03-28actual
Last update posted2025-10-27actual
Primary completion2026-10estimated (month precision)
Study completion2026-10estimated (month precision)

Assets

Drug assets

Sabirnetug

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Body weight of at least 30 kilograms (kg) (66 pounds [lbs]) and no more than 160 kg (352 lbs) at Screening
•Must consent to apolipoprotein E4 (APOE4) genotype status assessment
•Must meet all of the following criteria

1. National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or probable AD

2. Screening score between 22 and 30 (inclusive) on the Mini-Mental State Examination (MMSE)

3. Screening score of 0.5 or 1.0 on the Clinical Dementia Rating Global Score (CDR-GS) and Screening score ≥0.5 on the CDR Memory Box score

4. Evidence of cerebral amyloid accumulation by either PET scan or CSF

•If using cholinesterase inhibitors or memantine to treat symptoms related to AD, doses must be stable for at least three months (12 weeks) prior to Baseline and every attempt should be made to keep them at stable doses throughout the study
•Must have a reliable informant or study partner who is willing and able to perform all the roles as specified in the study partner Informed Consent Form (ICF)
•Female participants must be surgically sterile or be at least one-year post-menopausal. Male participants with a female partner of child-bearing potential must use adequate contraception

Exclusion criteria

•Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
•MRI of the brain that is inconsistent with MCI or AD or results showing greater than four ARIA-H, presence of any ARIA-E, or superficial siderosis
•History of significant or unstable neurological disease, other than AD, which may affect cognition or ability to complete the study, such as other dementias, serious infection of the brain, significant head trauma, uncontrolled seizures, stroke, or Parkinson´s disease
•Current serious or unstable clinically important illness that, in the judgment of the site investigator, is likely to affect cognitive assessment including visual and hearing impairment or affect the participant's safety or ability to complete the study
•Malignant disease in the last five years except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal posttreatment prostate-specific antibody (PSA)
•Geriatric Depression Scale-Short Form (GDS-SF) score >10 or current symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), criteria for major depressive disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the site investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
•Suicide risk, as determined by meeting any of the following criteria:

1. Any suicide attempt or preparatory acts/behavior on the C-SSRS Baseline/Screening in the last six months

2. Suicidal ideation in the last six months as defined by a positive response to Question 5 (Suicidal Ideation) on the C-SSRS Baseline/Screening

3. Significant risk of suicide, as judged by the site investigator

•Conditions that may affect cognitive assessments during the study
•Alcohol use disorder and/or substance use disorder within the last five years

Endpoints (33)

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

Global cognition
9
Amyloid biomarkers
6
Behavior / neuropsychiatric
3
Disease progression
3
Caregiver / quality of life
3
Safety / tolerability / PK
3
Fluid / digital biomarkers
2
Other (unclassified)
2
Function / daily living
1
Neuroimaging
1

Global cognition

9 endpoints
Primary/protocol endpoint

Change from Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score

Time frame:Baseline up to Week 80

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in ADAS-Cog13 Score

Time frame:Baseline up to Week 80

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame:Baseline up to Week 80

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

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Mini-Mental State Examination (MMSE)

Time frame:Baseline up to Week 80

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by CDR-SB

Time frame:Baseline up to Week 80

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

descriptive

Secondary/protocol endpoint

Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by MMSE

Time frame:Baseline up to Week 80

Mini-Mental State Examination (MMSE)

descriptive

Secondary/protocol endpoint

Percentage of Participants with No Clinical Progression at One Year

Time frame:Baseline up to Week 80

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

threshold achievement, improvement

Secondary/protocol endpoint

Correlation Between sabirnetug Exposure with Clinical Efficacy Measures

Time frame:Baseline up to 80 weeks

ADAS-Cog

descriptive

Secondary/protocol endpoint

Correlation Between Change in Biomarker that Reflect Disease Progression and Clinical Changes

Time frame:Up to 80 weeks

ADAS-Cog

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

Change from Baseline in ADCS-iADL Score

Time frame:Baseline up to Week 80

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score

Time frame:Baseline up to Week 80

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in EuroQoL 5-Dimension 5-Level (EQ-5D-5L)

Time frame:Baseline up to Week 80

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Suicidal Ideation and Behavior as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:Baseline up to Week 80

event count, event

Disease progression

3 endpoints
Secondary/protocol endpoint

Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by iADRS

Time frame:Baseline up to Week 80

descriptive

Secondary/protocol endpoint

Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADCS-iADL

Time frame:Baseline up to Week 80

descriptive

Secondary/protocol endpoint

Effect of sabirnetug on Clinical Progression as Compared to Placebo Assessed Using Time Saved Analysis as Measured by ADAS-Cog13

Time frame:Baseline up to Week 80

ADAS-Cog

descriptive

Amyloid biomarkers

6 endpoints
Secondary/protocol endpoint

Number of Participants with Amyloid-Related Imaging Abnormality with Edema/Effusions (ARIA-E) and ARIA with Hemorrhage/Hemosiderin Deposition (ARIA-H) as Measured by Magnetic Resonance Imaging (MRI)

Time frame:Baseline up to Week 80

event count, event

Secondary/protocol endpoint

Change From Baseline in Amyloid Plaque Load or Deposition Measured by Positron Emission Tomography (PET) in Centiloids

Time frame:Baseline up to Week 76

Amyloid PET Centiloid

change from baseline, improvement

Secondary/protocol endpoint

Target Engagement Assessed by Measurement of sabirnetug- Amyloid-β oligomer (AβO) Complex in CSF

Time frame:Up to Week 76

descriptive

Secondary/protocol endpoint

Change from Baseline in CSF Concentrations of Amyloid, Tau and Other Neurodegenerative Biomarkers

Time frame:Baseline up to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in CSF Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers in a Subset of Participants

Time frame:Baseline up to Week 76

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Blood Concentrations of Amyloid, Tau, and Other Neurodegenerative Biomarkers

Time frame:Baseline up to Week 76

change from baseline, improvement

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Volumetric Magnetic Resonance Imaging (vMRI) of Whole Brain Volume, Ventricular Volume, and Volume of Selected Regions of Interest

Time frame:Baseline up to Week 76

change from baseline, improvement

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

Concentration of sabirnetug in Cerebrospinal Fluid (CSF)

Time frame:Up to Week 76

concentration, descriptive

Secondary/protocol endpoint

CSF Concentrations of ACU193 in a Subset of Participants

Time frame:Up to Week 76

concentration, descriptive

Caregiver / quality of life

3 endpoints
Secondary/protocol endpoint

Change from Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)

Time frame:Baseline up to Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Resource Utilization in Dementia (RUD)

Time frame:Baseline up to Week 80

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Zarit Burden Interview (ZBI)

Time frame:Baseline up to Week 80

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of Participants with Treatment-Related Adverse Events (TEAEs)

Time frame:Baseline up to Week 80

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

Time frame:Baseline up to Week 80

event count, event

Secondary/protocol endpoint

Number of Participants who Discontinue or Withdraw due to TEAE

Time frame:Baseline up to Week 80

event count, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Number of Participants with Anti-Drug Antibodies (ADA) and Neutralizing Antibodies

Time frame:Baseline up to Week 80

event count, event

Secondary/protocol endpoint/low confidence

Serum Concentration of sabirnetug

Time frame:Pre-dose and multiple timepoints post dose up to 80 weeks

concentration, descriptive

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

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.