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
- Conditions
- Alzheimer's Disease (AD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT05291234
- Lead Sponsor
- AbbVie
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 106
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stage A: Placebo for ABBV-916 Placebo 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. Stage B: Placebo for ABBV-916 Placebo 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. Stage B: ABBV-916 Dose B ABBV-916 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. Stage A: ABBV-916 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. Stage B: ABBV-916 Dose A ABBV-916 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.
- Primary Outcome Measures
Name Time Method Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916 Up to approximately 24 weeks AUC of ABBV-916 will be determined.
Number of Participants Experiencing Adverse Events (AEs) 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: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916 Up to approximately 24 weeks T1/2 of ABBV-916 will be determined.
Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916 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 Up to approximately 24 weeks Tmax of ABBV-916 will be determined.
Stage A: Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-916 Up to approximately 24 weeks Apparent terminal phase elimination rate constant (β) of ABBV-916 will be determined.
Stage A: Cerebrospinal Fluid (CSF) Concentration as a Measure of ABBV-916 Crossing the Blood Brain Barrier 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 Up to approximately 24 weeks Antidrug antibody (ADA) classification and titers for positive ADA samples will be determined.
Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval Up to approximately 24 weeks Ctrough of ABBV-916 will be determined.
Stage B: Change in Brain Amyloid Plaque Deposition (Amyloid Centiloid Value) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Tucson Neuroscience Research /ID# 244957
🇺🇸Tucson, Arizona, United States
Irvine Clinical Research /ID# 239469
🇺🇸Irvine, California, United States
Alzheimer's Research and Treatment Center - Stuart /ID# 245477
🇺🇸Stuart, Florida, United States
Re:Cognition Health - Fairfax VA /ID# 239501
🇺🇸Fairfax, Virginia, United States
Advanced Memory Research Institute of NJ /ID# 239533
🇺🇸Toms River, New Jersey, United States
Keystone Clinical Studies LLC /ID# 239973
🇺🇸Plymouth Meeting, Pennsylvania, United States
Columbus Memory Center /ID# 245054
🇺🇸Columbus, Georgia, United States
Aventura Neurological Associates /ID# 243892
🇺🇸Aventura, Florida, United States
Syrentis Clinical Research /ID# 239682
🇺🇸Santa Ana, California, United States
Clinical Site Partners (CSP) - Orlando /ID# 245127
🇺🇸Winter Park, Florida, United States
Conquest Research /ID# 243916
🇺🇸Winter Park, Florida, United States
QUEST Research Institute /ID# 239459
🇺🇸Farmington Hills, Michigan, United States
Artemis Institute for Clinical Research - San Diego /ID# 244508
🇺🇸San Diego, California, United States
Pacific Research Network, Inc. /ID# 244083
🇺🇸San Diego, California, United States
Clinical Trials of Texas, Inc /ID# 244917
🇺🇸San Antonio, Texas, United States
Charter Research - Lady Lake /ID# 244657
🇺🇸Lady Lake, Florida, United States
JEM Research Institute /ID# 239122
🇺🇸Lake Worth, Florida, United States
ClinCloud LLC - Viera/Melbourne /ID# 240635
🇺🇸Melbourne, Florida, United States
Merritt Island Medical Research /ID# 239495
🇺🇸Merritt Island, Florida, United States
Optimus U /ID# 245868
🇺🇸Miami, Florida, United States
Renstar Medical Research /ID# 240153
🇺🇸Ocala, Florida, United States
Neurology Associates Ormond Beach /ID# 245527
🇺🇸Ormond Beach, Florida, United States
Allied Biomedical Res Inst Inc /ID# 244823
🇺🇸Miami, Florida, United States
Finlay Medical Research /ID# 245996
🇺🇸Miami, Florida, United States
Premiere Research Institute - Palm Beach /ID# 240108
🇺🇸West Palm Beach, Florida, United States
ClinCloud - Maitland /ID# 244507
🇺🇸Maitland, Florida, United States
K2 Medical Research - Ocoee /ID# 246849
🇺🇸Ocoee, Florida, United States
Alzheimer's Research and Treatment Center - Wellington /ID# 245201
🇺🇸Wellington, Florida, United States
IMIC Inc. Medical Research /ID# 245900
🇺🇸Palmetto Bay, Florida, United States
K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919
🇺🇸Orlando, Florida, United States
Charter Research - Winter Park /ID# 244778
🇺🇸Orlando, Florida, United States
Headlands Research - Orlando /ID# 239119
🇺🇸Orlando, Florida, United States