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

Status: Completed
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Tucson Neuroscience Research /ID# 244957
Tucson
California
Irvine Clinical Research /ID# 239469
Irvine
Artemis Institute for Clinical Research - San Diego /ID# 244508
San Diego
Pacific Research Network, Inc. /ID# 244083
San Diego
Syrentis Clinical Research /ID# 239682
Santa Ana
Florida
Aventura Neurological Associates /ID# 243892
Aventura
Charter Research - Lady Lake /ID# 244657
Lady Lake
JEM Research Institute /ID# 239122
Lake Worth
ClinCloud - Maitland /ID# 244507
Maitland
ClinCloud LLC - Viera/Melbourne /ID# 240635
Melbourne
Merritt Island Medical Research /ID# 239495
Merritt Island
Allied Biomedical Res Inst Inc /ID# 244823
Miami
Finlay Medical Research /ID# 245996
Miami
Optimus U /ID# 245868
Miami
Renstar Medical Research /ID# 240153
Ocala
K2 Medical Research - Ocoee /ID# 246849
Ocoee
Charter Research - Winter Park /ID# 244778
Orlando
Headlands Research - Orlando /ID# 239119
Orlando
K2 Medical Research - Orlando - South Orlando Avenue /ID# 243919
Orlando
Neurology Associates Ormond Beach /ID# 245527
Ormond Beach
IMIC Inc. Medical Research /ID# 245900
Palmetto Bay
Alzheimer's Research and Treatment Center - Stuart /ID# 245477
Stuart
Alzheimer's Research and Treatment Center - Wellington /ID# 245201
Wellington
Premiere Research Institute - Palm Beach /ID# 240108
West Palm Beach
Clinical Site Partners (CSP) - Orlando /ID# 245127
Winter Park
Conquest Research /ID# 243916
Winter Park
Georgia
Columbus Memory Center /ID# 245054
Columbus
Michigan
QUEST Research Institute /ID# 239459
Farmington Hills
New Jersey
Advanced Memory Research Institute of NJ /ID# 239533
Toms River
Pennsylvania
Keystone Clinical Studies LLC /ID# 239973
Plymouth Meeting
Texas
Clinical Trials of Texas, Inc /ID# 244917
San Antonio
Virginia
Re:Cognition Health - Fairfax VA /ID# 239501
Fairfax
Time Frame
Start Date: 2022-08-15
Completion Date: 2025-11-19
Participants
Target number of participants: 106
Treatments
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.
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.
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.
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.
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.
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov