Alzheimer's DiseasePhase 1/2NCT07599670
A Study to Assess the Safety and Effects of ABBV-1758 Following Subcutaneous or Intravenous Injections in Participants With Alzheimer's Disease
A Phase 1/2 study testing ABBV-1758 in people with Alzheimer's Disease, run by AbbVie at 13 sites in 2 countries.
Trial summary
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ABBV-1758
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 15 May 2026to Oct 2030
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants meeting all the following criteria for Alzheimer's disease (AD):
- In regions where timely testing is feasible (e.g., results available within 4 weeks of Visit 1), plasma biomarker that is predictive of elevated brain amyloid at Screening for participants that do not have known elevated brain amyloid based on previous amyloid positron emission tomography (PET) results.
- Participants with amyloid positron emission tomography PET scan results consistent with significant amyloid pathology (as determined by a Centiloid value of 50 or higher).
- Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.
Who cannot join
- Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.
- Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and/or any history of abnormal laboratory results that are indicative of significant disease(s).
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
- Participants with other significant pathological findings on brain MRI at screening, including but not limited to:
- Evidence of vasogenic edema
- 4 or more microhemorrhages (defined as 10 mm or less at the greatest diameter)
Show all 9Show fewer
- Any macrohemorrhage (defined as greater than 10 mm at the greatest diameter)
- Any superficial siderosis
- Severe white matter disease
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
United States11 sites, 11 recruiting
- Recruiting
Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856
Boulder, Colorado, 80301
- Recruiting
Key Clinical Research LLC /ID# 277800
Bradenton, Florida, 34207
Site Coordinator, 941-241-5539
- Recruiting
K2 Medical Research - Clermont /ID# 277859
Clermont, Florida, 34711
- Recruiting
Neurology Clinic - Cordova /ID# 277790
Cordova, Tennessee, 38018
- Recruiting
Kerwin Medical Center /ID# 277788
Dallas, Texas, 75231
Site Coordinator, 972-433-9100
- Recruiting
Irvine Center for Clinical Research /ID# 277752
Irvine, California, 92614
- Recruiting
K2 Medical Research - The Villages /ID# 278290
Lady Lake, Florida, 32159
- Recruiting
Alzheimer'S Research And Treatment Center - Stuart /ID# 278206
Stuart, Florida, 34997
- Recruiting
Adams Clinical /ID# 277754
Watertown, Massachusetts, 02472
- Recruiting
Alzheimer's Research And Treatment Center - Wellington /ID# 277749
Wellington, Florida, 33414
Site Coordinator, (561) 209-2400
- Recruiting
Conquest Research - Winter Park /ID# 277760
Winter Park, Florida, 32789
Site Coordinator, 407-916-0060
China2 sites, 2 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University /ID# 283310
Beijing, Beijing Municipality, 100053
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University /ID# 284295
Guangzhou, Guangdong, 510260
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.
ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.
Read more
Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.
- Conditions
- Alzheimer's Disease
- Being tested
- ABBV-1758, Placebo for ABBV-1758
- Keywords
- Alzheimer's Disease, ABBV-1758
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-1758Drug
Intravenous (IV) or Subcutaneous (SC)
Placebo for ABBV-1758Drug
Intravenous (IV) or Subcutaneous (SC)
ABBV-1758Drug
Subcutaneous (SC)
Placebo for ABBV-1758Drug
Subcutaneous (SC)
| Study group | Role | What they receive |
|---|---|---|
| Stage A-ABBV-1758 Dose A | Experimental | Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W). Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 Dose A | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage A-ABBV-1758 Dose B | Experimental | Participants will receive ABBV-1758 dose B Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 Dose B | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage A-ABBV-1758 Dose C | Experimental | Participants will receive ABBV-1758 dose C Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 Dose C | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage A-ABBV-1758 Dose D | Experimental | Participants will receive ABBV-1758 dose D Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 Dose D | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage B- ABBV-1758 - Expanded Cohort 1 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 - Expanded Cohort 1 | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage B- ABBV-1758- Expanded Cohort 2 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758- Expanded Cohort 2 | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage C- ABBV-1758 - Japanese Cohort 1 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758 - Japanese Cohort 1 | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage C- ABBV-1758- Japanese Cohort 2 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758- Japanese Cohort 2 | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
| Stage C- ABBV-1758-Chinese Cohort | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. Receives: Drug: ABBV-1758 |
| Placebo for ABBV-1758- Chinese Cohort | Placebo comparator | Participants will receive Placebo for ABBV-1758. Receives: Drug: Placebo for ABBV-1758 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Measured: Up to approximately 40 weeks
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Measured: Up to approximately 40 weeks
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
Measured: Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Measured: Up to approximately 40 weeks
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Measured: Up to approximately 40 weeks
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Measured: Up to approximately 40 weeks
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Measured by amyloid positron emission tomography (PET)
Measured: Up to approximately 28 Weeks
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Cmax of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Tmax of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Ctrough of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758
AUCtau of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Cav,ss of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
AUCtau of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Total Body Clearance (CL) of ABBV-1758
CL of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
CL/F of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Volume of Distribution at Steady-State (Vss)
Vss of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Vz of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
β of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Terminal phase elimination half-life of ABBV-1758
Measured: Up to approximately 40 weeks
Stage A and C: Effective Half-Life (T1/2,eff)
T1/2,eff of ABBV-1758
Measured: Up to approximately 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start15 May 2026
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599670
- Sponsor's protocol ID
- M25-804
- Status last verified
- Sep 2026
- First submitted
- 15 May 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ABBV-1758 in Participants With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07599670
- Acronym / sponsor ID
- M25-804
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, ABBV-1758
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alzheimer's disease (AD) is a progressive, irreversible neurological disorder and is the most common cause of dementia in the elderly population. Clinical symptoms of the disease may begin with occasional forgetfulness such as misplacement of items, forgetting important dates or events, and may progress to noticeable memory loss, increased confusion and agitation, and eventually, loss of independence and non-responsiveness. The purpose of this study is to test how safe ABBV-1758 is, how well it works, how the body processes it and what effects it has on the body.
ABBV-1758 is an investigational drug being developed for the treatment of Alzheimer's disease. This study is conducted in 3 stages. Stage A is a multiple ascending dose study with a 1 in 5 chance (4:1 randomization) that participants are assigned to receive placebo. Stage B is a dose expansion phase, also using 4:1 randomization for ABBV-1758 or placebo. Stage C enrolls Japanese and Chinese participants with the same randomization scheme. Approximately 210 participants will be enrolled at about 55 sites in the United States, China, and Japan.
Participants will receive intravenous (IV) or subcutaneous (SC) doses of ABBV-1758 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for additional 12 weeks in the Follow-up Period. Participants will have the option of participating in a 12-month, blinded Extension Period receiving ABBV-1758 or placebo based on amyloid PET results.
There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The safety of the treatment will be checked by medical assessments, blood tests, and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| Stage A-ABBV-1758 Dose A | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W). |
| Placebo for ABBV-1758 Dose A | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose B | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose B Q4W. |
| Placebo for ABBV-1758 Dose B | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose C | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose C Q4W. |
| Placebo for ABBV-1758 Dose C | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage A-ABBV-1758 Dose D | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose D Q4W. |
| Placebo for ABBV-1758 Dose D | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage B- ABBV-1758 - Expanded Cohort 1 | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758 - Expanded Cohort 1 | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage B- ABBV-1758- Expanded Cohort 2 | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Expanded Cohort 2 | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758 - Japanese Cohort 1 | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758 - Japanese Cohort 1 | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758- Japanese Cohort 2 | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Japanese Cohort 2 | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
| Stage C- ABBV-1758-Chinese Cohort | Experimental | Drug: ABBV-1758Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
| Placebo for ABBV-1758- Chinese Cohort | Placebo comparator | Drug: Placebo for ABBV-1758Participants will receive Placebo for ABBV-1758. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants meeting all the following criteria for Alzheimer's disease (AD):
- Participants must have a Mini-Mental State Examination (MMSE) score of 20 or higher at Screening.
Key exclusion criteria (9 listed)
- Participants with screening magnetic resonance imaging (MRI) that show evidence of another potential etiology for progressive dementia.
- Participants who have any current serious conditions or illnesses that are not adequately controlled, or any conditions that, in the investigator's opinion, could interfere with the analyses in this study, including but not limited to psychiatric, neurologic (other than AD), cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, immunologic, or hematologic, metabolic, pulmonary, ophthalmologic, dermatologic, and/or any history of abnormal laboratory results that are indicative of significant disease(s).
- Participants who had prior exposure to ABBV-1758 or any history of exposure to anti-amyloid beta monoclonal antibody (mAb) treatment.
- Participants with other significant pathological findings on brain MRI at screening, including but not limited to:
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 |
|---|---|---|
| ABBV-1758Intravenous (IV) or Subcutaneous (SC) | Drug | Stage A-ABBV-1758 Dose D, Stage B- ABBV-1758 - Expanded Cohort 1, Stage B- ABBV-1758- Expanded Cohort 2, Stage C- ABBV-1758 - Japanese Cohort 1, Stage C- ABBV-1758- Japanese Cohort 2, Stage C- ABBV-1758-Chinese Cohort |
| Placebo for ABBV-1758Intravenous (IV) or Subcutaneous (SC) | Drug | Placebo for ABBV-1758 - Expanded Cohort 1, Placebo for ABBV-1758 - Japanese Cohort 1, Placebo for ABBV-1758 Dose D, Placebo for ABBV-1758- Chinese Cohort, Placebo for ABBV-1758- Expanded Cohort 2, Placebo for ABBV-1758- Japanese Cohort 2 |
| ABBV-1758Subcutaneous (SC) | Drug | Stage A-ABBV-1758 Dose A, Stage A-ABBV-1758 Dose B, Stage A-ABBV-1758 Dose C |
| Placebo for ABBV-1758Subcutaneous (SC) | Drug | Placebo for ABBV-1758 Dose A, Placebo for ABBV-1758 Dose B, Placebo for ABBV-1758 Dose C |
Primary outcome
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 40 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Percentage of Participants with Abnormal Change from Baseline in Clinical Laboratory Test Results
Time frame: Up to approximately 40 weeks
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Percentage of Participants With Amyloid-Related Imaging Abnormalities (ARIA)
Time frame: Up to approximately 40 weeks
Amyloid related imaging abnormalities represent a spectrum of magnetic resonance imaging findings primarily observed in participants undergoing treatment with anti-amyloid therapies.
Percentage of Participants with Abnormal Change From Baseline in Vital Sign Measurements
Time frame: Up to approximately 40 weeks
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Percentage of Participants with Abnormal Change From Baseline in Electrocardiograms (ECGs) Parameters
Time frame: Up to approximately 40 weeks
12-lead resting ECGs will be recorded. Parameters include heart rate, PR interval, QT interval, QRS duration, and QT interval corrected using Fridericia's formula (QTcF).
Percentage of Participants Experiencing Any Suicidal Ideation or Suicidal Behavior As Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 40 weeks
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Stage A, B, and C: Change from Baseline in Brain Amyloid Load
Time frame: Up to approximately 28 Weeks
Measured by amyloid positron emission tomography (PET)
Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758
Time frame: Up to approximately 40 weeks
Cmax of ABBV-1758
Stage A and C: Time to Cmax (Tmax) of ABBV-1758
Time frame: Up to approximately 40 weeks
Tmax of ABBV-1758
Stage A and C: Trough Concentration measured at the end of a dosing interval at steady state (Ctrough) of ABBV-1758
Time frame: Up to approximately 40 weeks
Ctrough of ABBV-1758
Stage A and C: Area under the Plasma Concentration-time Curve from Time Zero to the End of the Dosing Interval (AUCtau) of ABBV-1758
Time frame: Up to approximately 40 weeks
AUCtau of ABBV-1758
Stage A and C: Average Serum Concentration at Steady-State (Cav,ss) of ABBV-1758
Time frame: Up to approximately 40 weeks
Cav,ss of ABBV-1758
Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758
Time frame: Up to approximately 40 weeks
AUCtau of ABBV-1758
Stage A and C: Total Body Clearance (CL) of ABBV-1758
Time frame: Up to approximately 40 weeks
CL of ABBV-1758
Stage A and C: Apparent Clearance (CL/F) of ABBV-1758
Time frame: Up to approximately 40 weeks
CL/F of ABBV-1758
Stage A and C: Volume of Distribution at Steady-State (Vss)
Time frame: Up to approximately 40 weeks
Vss of ABBV-1758
Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz)
Time frame: Up to approximately 40 weeks
Vz of ABBV-1758
Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758
Time frame: Up to approximately 40 weeks
β of ABBV-1758
Stage A and C: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1758
Time frame: Up to approximately 40 weeks
Terminal phase elimination half-life of ABBV-1758
Stage A and C: Effective Half-Life (T1/2,eff)
Time frame: Up to approximately 40 weeks
T1/2,eff of ABBV-1758
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Related trials for Alzheimer's Disease
RecruitingPhase 3
Nabilone for Agitation Blinded Intervention Trial
Alzheimer Disease, Agitation
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
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.
ABBVIE INC. study director
AbbVie
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABBV-1758 in people with Alzheimer's Disease, run by AbbVie at 13 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, China. 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?
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?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 40 weeks). The study lists 20 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 18 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.