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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage A-ABBV-1758 Dose A | Experimental | Participants will receive ABBV-1758 dose A once every 4 weeks (Q4W). |
|
| Placebo for ABBV-1758 Dose A | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
|
| Stage A-ABBV-1758 Dose B | Experimental | Participants will receive ABBV-1758 dose B Q4W. |
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| Placebo for ABBV-1758 Dose B | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
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| Stage A-ABBV-1758 Dose C | Experimental | Participants will receive ABBV-1758 dose C Q4W. |
|
| Placebo for ABBV-1758 Dose C | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-1758 | Drug | Intravenous (IV) or Subcutaneous (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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). | 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) |
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Inclusion Criteria:
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.
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irvine Center for Clinical Research /ID# 277752 | Recruiting | Irvine | California | 92614 | United States | |
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.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Stage A-ABBV-1758 Dose D | Experimental | Participants will receive ABBV-1758 dose D Q4W. |
|
| Placebo for ABBV-1758 Dose D | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
|
| Stage B- ABBV-1758 - Expanded Cohort 1 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
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| Placebo for ABBV-1758 - Expanded Cohort 1 | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
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| Stage B- ABBV-1758- Expanded Cohort 2 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
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| Placebo for ABBV-1758- Expanded Cohort 2 | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
|
| Stage C- ABBV-1758 - Japanese Cohort 1 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
|
| Placebo for ABBV-1758 - Japanese Cohort 1 | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
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| Stage C- ABBV-1758- Japanese Cohort 2 | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
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| Placebo for ABBV-1758- Japanese Cohort 2 | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
|
| Stage C- ABBV-1758-Chinese Cohort | Experimental | Participants will receive ABBV-1758 dose determined in Stage A Q4W. |
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| Placebo for ABBV-1758- Chinese Cohort | Placebo Comparator | Participants will receive Placebo for ABBV-1758. |
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| Placebo for ABBV-1758 | Drug | Intravenous (IV) or Subcutaneous (SC) |
|
| ABBV-1758 | Drug | Subcutaneous (SC) |
|
| Placebo for ABBV-1758 | Drug | Subcutaneous (SC) |
|
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. |
| Up to approximately 40 weeks |
| Stage A, B, and C: Change from Baseline in Brain Amyloid Load | Measured by amyloid positron emission tomography (PET) | Up to approximately 28 Weeks |
| Stage A and C: Maximum Plasma Concentration (Cmax) of ABBV-1758 | Cmax of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Time to Cmax (Tmax) of ABBV-1758 | Tmax of ABBV-1758 | 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 | 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 | 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 | Up to approximately 40 weeks |
| Stage A and C: Accumulation ratio for (AUCtau) of ABBV-1758 | AUCtau of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Total Body Clearance (CL) of ABBV-1758 | CL of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Apparent Clearance (CL/F) of ABBV-1758 | CL/F of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Volume of Distribution at Steady-State (Vss) | Vss of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Apparent Volume of Distribution during the Terminal Phase (Vz) | Vz of ABBV-1758 | Up to approximately 40 weeks |
| Stage A and C: Terminal Phase Elimination Rate Constant (β) of ABBV-1758 | β of ABBV-1758 | 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 | Up to approximately 40 weeks |
| Stage A and C: Effective Half-Life (T1/2,eff) | T1/2,eff of ABBV-1758 | Up to approximately 40 weeks |
| Alpine Clinical Research Center - Boulder - 47th Street /ID# 277856 |
| Recruiting |
| Boulder |
| Colorado |
| 80301 |
| United States |
| Key Clinical Research LLC /ID# 277800 | Recruiting | Bradenton | Florida | 34207 | United States |
|
| K2 Medical Research - Clermont /ID# 277859 | Recruiting | Clermont | Florida | 34711 | United States |
| K2 Medical Research - The Villages /ID# 278290 | Recruiting | Lady Lake | Florida | 32159 | United States |
| Alzheimer'S Research And Treatment Center - Stuart /ID# 278206 | Recruiting | Stuart | Florida | 34997 | United States |
| Alzheimer's Research And Treatment Center - Wellington /ID# 277749 | Recruiting | Wellington | Florida | 33414 | United States |
|
| Conquest Research - Winter Park /ID# 277760 | Recruiting | Winter Park | Florida | 32789 | United States |
|
| Adams Clinical /ID# 277754 | Recruiting | Watertown | Massachusetts | 02472 | United States |
| Neurology Clinic - Cordova /ID# 277790 | Recruiting | Cordova | Tennessee | 38018 | United States |
| Kerwin Medical Center /ID# 277788 | Recruiting | Dallas | Texas | 75231 | United States |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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