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

Alzheimer's Disease (AD) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05291234
• Other study ID #: M22-721
• Secondary ID: 2022-500691-59-0
• Status: Recruiting
• Phase: Phase 2
• Start date: August 15, 2022
• Est. completion date: March 26, 2031

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 195
• Est. completion date: March 26, 2031
• Est. primary completion date: March 26, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)

Intervention

Drug:
• ABBV-916
Intravenous administration
• Placebo
Intravenous administration

Locations

Country	Name	City	State
United States	Aventura Neurological Associates /ID# 243892	Aventura	Florida
United States	Columbus Memory Center /ID# 245054	Columbus	Georgia
United States	Re:Cognition Health - Fairfax VA /ID# 239501	Fairfax	Virginia
United States	QUEST Research Institute /ID# 239459	Farmington Hills	Michigan
United States	Irvine Clinical Research /ID# 239469	Irvine	California
United States	Charter Research - Lady Lake /ID# 244657	Lady Lake	Florida
United States	JEM Research Institute /ID# 239122	Lake Worth	Florida
United States	ClinCloud - Maitland /ID# 244507	Maitland	Florida
United States	ClinCloud LLC - Viera/Melbourne /ID# 240635	Melbourne	Florida
United States	Merritt Island Medical Research /ID# 239495	Merritt Island	Florida
United States	Allied Biomedical Res Inst Inc /ID# 244823	Miami	Florida
United States	Finlay Medical Research /ID# 245996	Miami	Florida
United States	Optimus U /ID# 245868	Miami	Florida
United States	Renstar Medical Research /ID# 240153	Ocala	Florida
United States	K2 Medical Research - Ocoee /ID# 246849	Ocoee	Florida
United States	Charter Research - Winter Park /ID# 244778	Orlando	Florida
United States	Headlands Research - Orlando /ID# 239119	Orlando	Florida
United States	K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919	Orlando	Florida
United States	Neurology Associates Ormond Beach /ID# 245527	Ormond Beach	Florida
United States	IMIC Inc. Medical Research /ID# 245900	Palmetto Bay	Florida
United States	Keystone Clinical Studies LLC /ID# 239973	Plymouth Meeting	Pennsylvania
United States	Clinical Trials of Texas, Inc /ID# 244917	San Antonio	Texas
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	Syrentis Clinical Research /ID# 239682	Santa Ana	California
United States	Alzheimer's Research and Treatment Center - Stuart /ID# 245477	Stuart	Florida
United States	Advanced Memory Research Institute of NJ /ID# 239533	Toms River	New Jersey
United States	Tucson Neuroscience Research /ID# 244957	Tucson	Arizona
United States	Alzheimer's Research and Treatment Center - Wellington /ID# 245201	Wellington	Florida
United States	Premiere Research Institute - Palm Beach /ID# 240108	West Palm Beach	Florida
United States	Clinical Site Partners (CSP) - Orlando /ID# 245127	Winter Park	Florida
United States	Conquest Research /ID# 243916	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 160 weeks
Primary	Stage A: Maximum Observed Serum Concentration (Cmax) for Multiple Ascending Dose of ABBV-916	Cmax of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	Stage A: Time to Cmax (Tmax) for Multiple Ascending Dose of ABBV-916	Tmax of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	Stage A: Apparent Terminal Phase Elimination Rate Constant (ß) of ABBV-916	Apparent terminal phase elimination rate constant (ß) of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	Stage A: Terminal Phase Elimination Half-Life (t1/2) of ABBV-916	T1/2 of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	Stage A: Trough Serum Concentration (Ctrough) of ABBV-916 at the End of a Dosing Interval	Ctrough of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	Stage A: Area Under the Concentration-Time Curve (AUC) of ABBV-916	AUC of ABBV-916 will be determined.	Up to approximately 24 weeks
Primary	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.	Up to approximately 24 weeks
Primary	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.	Up to approximately 24 weeks
Primary	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.	Baseline (Week 0) through Week 24

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