A Study to Assess Safety of ABBV-916 and How Intravenous ABBV-916 Moves Through Body and Affects Brain Amyloid Plaque Clearance in Adult Participants (Aged 50-90 Years) With Early Alzheimer's Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05291234 |
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Recruitment Status :
Recruiting
First Posted : March 22, 2022
Last Update Posted : April 8, 2024
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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. This study will assess how safe and effective ABBV-916 is in treating early AD. Adverse events, change in disease activity, and how ABBV-916 moves through body of participants will be assessed.
ABBV-916 is an investigational drug being developed for the treatment of early AD. This study is conducted in 2 stages. Stage A is a multiple ascending dose study. There is a 1 in 4 chance that participants are assigned to receive placebo. Stage B is a proof-of-concept study. In Stage B, there is a 1 in 5 chance that participants will be assigned to receive placebo. The first 6 months of this study are "double-blind," which means that neither the trial participant nor the study doctors know which treatments will be given. This will be followed by a 2-year extension period in which all participants will receive ABBV-916. Approximately 195 participants aged 50-90 years will be enrolled in about 90 sites across the world.
Participants will receive intravenous (IV) doses of ABBV-916 or placebo once every 4 weeks (Q4W) for 24 weeks and will be followed for an additional 16 weeks. Participants will have the option of participating in a 2-year, open-label, Extension Period receiving IV ABBV-916.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, magnetic resonance imaging (MRI), blood tests, checking for side effects and completing questionnaires.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease (AD) | Drug: ABBV-916 Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 195 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-916 in Subjects With Early Alzheimer's Disease |
| Actual Study Start Date : | August 15, 2022 |
| Estimated Primary Completion Date : | March 26, 2031 |
| Estimated Study Completion Date : | March 26, 2031 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Stage A: ABBV-916
Participants will receive ABBV-916 for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
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Drug: ABBV-916
Intravenous administration |
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Placebo Comparator: Stage A: Placebo for ABBV-916
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
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Drug: Placebo
Intravenous administration |
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Experimental: Stage B: ABBV-916 Dose A
Participants will receive ABBV-916 Dose A for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
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Drug: ABBV-916
Intravenous administration |
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Placebo Comparator: Stage B: Placebo for ABBV-916
Participants will receive Placebo for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
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Drug: Placebo
Intravenous administration |
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Experimental: Stage B: ABBV-916 Dose B
Participants will receive ABBV-916 Dose B for 24 weeks. Participants at the end of 24 weeks will have the option of participating in the 2-year Extension Period.
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Drug: ABBV-916
Intravenous administration |
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 160 weeks ]An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
- Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]Cmax of ABBV-916 will be determined.
- Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]Tmax of ABBV-916 will be determined.
- Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.
- Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]T1/2 of ABBV-916 will be determined.
- Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval [ Time Frame: Up to approximately 24 weeks ]Ctrough of ABBV-916 will be determined.
- Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]AUC of ABBV-916 will be determined.
- Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier [ Time Frame: Up to approximately 24 weeks ]The central value for ratio of ABBV-916 concentration in cerebrospinal fluid (CSF) to that in serum will be estimated for evaluation of the fraction of ABBV-916 crossing the blood brain barrier.
- Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916 [ Time Frame: Up to approximately 24 weeks ]Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.
- Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value) [ Time Frame: Baseline (Week 0) through Week 24 ]Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Diagnosis of Stage 3 or Stage 4 Alzheimer's disease (AD) based on the 2018 National Institute on Aging (NIA)-Alzheimer's Association (AA) Research Framework Criteria.
- Mini-Mental State Examination (MMSE) score of 20 to 28, inclusive, at Screening.
- Blood-based biomarker results with a value consistent with amyloid positron emission tomography (PET) positivity. The biomarker will be chosen by the sponsor and described in the Laboratory Manual. Biomarker results will not be required for eligibility if the participant has a positive Amyloid PET scan meeting the central reader criteria.
- Amyloid PET scan results consistent with amyloid pathology.
- Stage B: Participants must have a study partner who spends a minimum average of 10 hours per week with the participant.
Exclusion Criteria:
- Significant pathological findings on brain MRI at screening including, but not limited to, evidence of vasogenic edema, 4 or more microhemorrhages, any macrohemorrhages, any superficial siderosis, or severe white matter disease.
- Any anticoagulants or have a bleeding disorder that is not adequately controlled.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05291234
| Contact: ABBVIE CALL CENTER | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
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| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT05291234 |
| Other Study ID Numbers: |
M22-721 2022-500691-59-00 ( Other Identifier: EU CT ) |
| First Posted: | March 22, 2022 Key Record Dates |
| Last Update Posted: | April 8, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/ |
| Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ |
| URL: | https://vivli.org/ourmember/abbvie/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Alzheimer's Disease (AD) Early Alzheimer's Disease ABBV-916 |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |