Alzheimer's Disease (AD)Phase 2NCT05291234
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
A Phase 2 study testing ABBV-916 in people with Alzheimer's Disease (AD), run by AbbVie at 32 sites in United States.
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 (AD)
- What is being tested?
- ABBV-916
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 32 sitesUnited States
- Study dates
- 15 Aug 2022to 19 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Aventura Neurological Associates /ID# 243892
Aventura, Florida, 33180
Columbus Memory Center /ID# 245054
Columbus, Georgia, 31909
Re:Cognition Health - Fairfax VA /ID# 239501
Fairfax, Virginia, 22031-5207
QUEST Research Institute /ID# 239459
Farmington Hills, Michigan, 48334-2977
Irvine Clinical Research /ID# 239469
Irvine, California, 92614
Charter Research - Lady Lake /ID# 244657
Lady Lake, Florida, 32162
JEM Research Institute /ID# 239122
Lake Worth, Florida, 33462-1141
ClinCloud - Maitland /ID# 244507
Maitland, Florida, 32751
ClinCloud LLC - Viera/Melbourne /ID# 240635
Melbourne, Florida, 32940-8288
Merritt Island Medical Research /ID# 239495
Merritt Island, Florida, 32952-3616
Optimus U /ID# 245868
Miami, Florida, 33125-4013
Finlay Medical Research /ID# 245996
Miami, Florida, 33126
Allied Biomedical Res Inst Inc /ID# 244823
Miami, Florida, 33155
Renstar Medical Research /ID# 240153
Ocala, Florida, 34470
K2 Medical Research - Ocoee /ID# 246849
Ocoee, Florida, 34761-4547
K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919
Orlando, Florida, 32751
Charter Research - Winter Park /ID# 244778
Orlando, Florida, 32803-1839
Headlands Research - Orlando /ID# 239119
Orlando, Florida, 32819
Neurology Associates Ormond Beach /ID# 245527
Ormond Beach, Florida, 32174
IMIC Inc. Medical Research /ID# 245900
Palmetto Bay, Florida, 33157
Keystone Clinical Studies LLC /ID# 239973
Plymouth Meeting, Pennsylvania, 19462
Clinical Trials of Texas, Inc /ID# 244917
San Antonio, Texas, 78229
Artemis Institute for Clinical Research - San Diego /ID# 244508
San Diego, California, 92103-2204
Pacific Research Network, Inc. /ID# 244083
San Diego, California, 92103
Syrentis Clinical Research /ID# 239682
Santa Ana, California, 92705
Alzheimer's Research and Treatment Center - Stuart /ID# 245477
Stuart, Florida, 34997-5765
Advanced Memory Research Institute of NJ /ID# 239533
Toms River, New Jersey, 08755-5043
Tucson Neuroscience Research /ID# 244957
Tucson, Arizona, 85710-6152
Alzheimer's Research and Treatment Center - Wellington /ID# 245201
Wellington, Florida, 33414
Premiere Research Institute - Palm Beach /ID# 240108
West Palm Beach, Florida, 33407-3209
Clinical Site Partners (CSP) - Orlando /ID# 245127
Winter Park, Florida, 32789-4681
Conquest Research /ID# 243916
Winter Park, Florida, 32789
About this study
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
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.
Read more
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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- ABBV-916, Placebo
- Keywords
- Alzheimer's Disease (AD), Early Alzheimer's Disease, ABBV-916
- 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-916Drug
Intravenous administration
PlaceboDrug
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Stage A: ABBV-916 | Experimental | 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. Receives: Drug: ABBV-916 |
| Stage A: Placebo for ABBV-916 | Placebo comparator | 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. Receives: Drug: Placebo |
| Stage B: ABBV-916 Dose A | Experimental | 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. Receives: Drug: ABBV-916 |
| Stage B: Placebo for ABBV-916 | Placebo comparator | 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. Receives: Drug: Placebo |
| Stage B: ABBV-916 Dose B | Experimental | 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. Receives: Drug: ABBV-916 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
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.
Measured: Up to approximately 160 weeks
Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916
Cmax of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916
Tmax of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916
Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916
T1/2 of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval
Ctrough of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916
AUC of ABBV-916 will be determined.
Measured: Up to approximately 24 weeks
Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier
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.
Measured: Up to approximately 24 weeks
Stage A: Percentage of Participants With Antidrug Antibodies (ADA) as a Measure of Immunogenicity Following Multiple Ascending Dose of ABBV-916
Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.
Measured: Up to approximately 24 weeks
Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value)
Change from baseline in brain amyloid plaque deposition (amyloid centiloid value) is measured by amyloid positron emission tomography (PET) scan.
Measured: Baseline (Week 0) through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start15 Aug 2022
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's Disease (AD)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
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
- NCT05291234
- Sponsor's protocol ID
- M22-721
- Other IDs
- 2022-500691-59-00
- Status last verified
- Dec 2025
- First submitted
- 21 Mar 2022
- Last updated
- 10 Dec 2025
- 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.
Publications
Lynch SY, Wang Y, Wang D, Bachhav SS, Xiong H, Boiser J, Stage E, Bannon AW, Graff O, Florian H. A randomized phase 1b/2 trial of ABBV-916 in adults with early Alzheimer's disease. Alzheimers Dement. 2026 Aug;22(8):e71715. doi: 10.1002/alz.71715.
PubMed 42565245
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05291234
- Acronym / sponsor ID
- M22-721
- Conditions
- Alzheimer's Disease (AD)
- Keywords
- Alzheimer's Disease (AD), Early Alzheimer's Disease, ABBV-916
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 22 Mar 2022 (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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage A: ABBV-916 | Experimental | Drug: ABBV-916Participants 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. |
| Stage A: Placebo for ABBV-916 | Placebo comparator | Drug: PlaceboParticipants 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. |
| Stage B: ABBV-916 Dose A | Experimental | Drug: ABBV-916Participants 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. |
| Stage B: Placebo for ABBV-916 | Placebo comparator | Drug: PlaceboParticipants 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. |
| Stage B: ABBV-916 Dose B | Experimental | Drug: ABBV-916Participants 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. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- 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.
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-916Intravenous administration | Drug | Stage A: ABBV-916, Stage B: ABBV-916 Dose A, Stage B: ABBV-916 Dose B |
| PlaceboIntravenous administration | Drug | Stage A: Placebo for ABBV-916, Stage B: Placebo for ABBV-916 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 42565245Lynch SY, Wang Y, Wang D, Bachhav SS, Xiong H, Boiser J, Stage E, Bannon AW, Graff O, Florian H. A randomized phase 1b/2 trial of ABBV-916 in adults with early Alzheimer's disease. Alzheimers Dement. 2026 Aug;22(8):e71715. doi: 10.1002/alz.71715.
- 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.
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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.
ABBVIE INC. study director
AbbVie
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABBV-916 in people with Alzheimer's Disease (AD), run by AbbVie at 32 sites in United States.
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 5 inclusion and 2 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 160 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05291234, which also lists 1 linked publication.
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 10 Dec 2025.