Clinical trial NCT05771428: Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-552 Capsules Moves Through the Body of Participants Aged 50 to 90 Years With Mild Alzheimer's Disease
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of ABBV-552 in Participants With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease (AD)
Keywords: Alzheimer's disease (AD)
Dementia
ABBV-552
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-03-16
Enrollment: 263
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-552 is in treating symptoms of early AD. Adverse events, change in disease activity, how ABBV-552 moves through body of participants and the body response to ABBV-552 will be assessed.

ABBV-552 is an investigational drug being developed for the treatment of Alzheimer's disease (AD). Study doctors put the participants in 1 of 4 groups (3 active dose groups and a placebo group), called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to placebo. Approximately 240 participants aged 50-90 years with mild AD will be enrolled in approximately 60 sites across the world.

Participants will receive oral ABBV-552 or placebo capsules once daily for 12 weeks and followed for 30 days after the last dose of study drug.

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, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease according to the National Institute of Aging-Alzheimer's Association (NIA-AA) (2011) criteria.
* Mini-Mental State Examination (MMSE) score of 20 to 26, a Clinical Dementia Rating (CDR) global score of 0.5 or 1.0, with a CDR memory score of 0.5 or higher, and at least 1 CDR functional domain (community affairs, home and hobbies, or personal care) score of 0.5 or higher at Screening Visit 1.

Exclusion Criteria:

- Clinically significant and/or unstable medical conditions or any other reason that the investigator determines would interfere with participation in this study (e.g., unlikely to adhere to the study or procedures, keep appointments, or is planning to relocate during the study) or would make the participant an unsuitable candidate to receive ABBV-552.

Primary outcomes:
measure: Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score
timeFrame: From Baseline (Week 0) through Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Irvine Clinical Research /ID# 250030
state: California
city: Long Beach
country: United States
facility: Alliance for Research Alliance for Wellness /ID# 246492
state: California
city: Los Alamitos
country: United States
facility: Wake Research - Pharmacology Research Institute (WR-PRI), LLC (Alamitos) /ID# 248891
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research /ID# 246488
state: Connecticut
city: Clermont
country: United States
facility: Vertex Research Group Inc /ID# 248295
state: Florida
city: Greenacres City
country: United States
facility: Finlay Medical Research - West Palm Beach /ID# 246970
state: Florida
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research - Hallandale Beach /ID# 246896
state: Florida
city: Hialeah
country: United States
facility: New Life Medical Research Center - Hialeah /ID# 247536
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research - The Villages /ID# 250820
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Res Inst Inc /ID# 246971
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group /ID# 247670
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center /ID# 248298
state: Florida
city: Ocoee
country: United States
facility: K2 Medical Research - Ocoee /ID# 251029
state: Florida
city: Okeechobee
country: United States
facility: Health Synergy Clinical Research LLC /ID# 247726
state: Florida
city: Orlando
country: United States
facility: K2 Medical Research - Orlando - South Orlando Avenue /ID# 250904
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV /ID# 247697
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Research and Treatment Center - Stuart /ID# 246484
state: Florida
city: Wellington
country: United States
facility: Alzheimer's Research and Treatment Center - Wellington /ID# 246491
state: Florida
city: Winter Park
country: United States
facility: Conquest Research /ID# 262078
state: Florida
city: Columbus
country: United States
facility: Columbus Memory Center /ID# 249534
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials /ID# 248663
state: Idaho
city: Fort Wayne
country: United States
facility: Allied Physicians - Fort Wayne Neurological Center /ID# 248300
state: Indiana
city: Indianapolis
country: United States
facility: Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky HealthCare - Turfland /ID# 251139
state: Kentucky
city: Alexandria
country: United States
facility: NeuroMedical Clinic of Central Louisiana /ID# 246960
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC /ID# 246973
state: Louisiana
city: Watertown
country: United States
facility: Adams Clinical /ID# 248358
state: Massachusetts
city: Raleigh
country: United States
facility: Velocity Clinical Research, Inc /ID# 249837
state: North Carolina
city: Beavercreek
country: United States
facility: American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930
state: Ohio
city: Canton
country: United States
facility: NeuroScience Research Center - Canton /ID# 248552
state: Ohio
city: Dayton
country: United States
facility: Neurology Diagnostics - South /ID# 246931
state: Ohio
city: Portland
country: United States
facility: Summit Headlands LLC /ID# 250678
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center /ID# 248801
state: Tennessee
city: Dallas
country: United States
facility: Kerwin Medical Center /ID# 248662
state: Texas
city: El Paso
country: United States
facility: ANESC Research LLC /ID# 246958
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research /ID# 249141
state: Texas
city: Norfolk
country: United States
facility: Sentara Neurology Specialists - Norfolk /ID# 248578
state: Virginia
city: Darlinghurst
country: Australia
facility: St Vincent's Centre for Applied Medical Research /ID# 249843
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology - Kogarah /ID# 249098
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital /ID# 249095
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Res Fou /ID# 249097
state: Western Australia
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes /ID# 248077
city: Otake-shi
country: Japan
facility: NHO Hiroshima-Nishi Medical center /ID# 256947
state: Hiroshima
city: Fujisawa-shi
country: Japan
facility: Kawashima Neurology Clinic /ID# 253561
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital /ID# 256664
state: Kanagawa
city: Kawasaki
country: Japan
facility: Teikyo University Mizonokuchi Hospital /ID# 253259
state: Kanagawa
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital /ID# 252564
state: Nara
city: Kashiwazaki-shi
country: Japan
facility: NHO Niigata National Hospital /ID# 254207
state: Niigata
city: Yufu City
country: Japan
facility: Oita University Hospital /ID# 253679
state: Oita
city: Kanzaki-gun
country: Japan
facility: Hizen Psychiatric Center /ID# 252363
state: Saga
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 252373
state: Tokyo
city: Christchurch
country: New Zealand
facility: CGM Research Trust /ID# 249439
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya /ID# 249100
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua Terrassa /ID# 248448
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla /ID# 248454
state: Cantabria
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra - Pamplona /ID# 248415
state: Navarra
city: Madrid
country: Spain
facility: Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 249101
city: Bristol
country: United Kingdom
facility: Re:Cognition Health Bristol /ID# 249795
state: Bristol, City Of
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health Birmingham /ID# 249796
city: London
country: United Kingdom
facility: St Pancras Clinical Research /ID# 249006
city: London
country: United Kingdom
facility: Re:Cognition Health - London /ID# 249005
city: Motherwell
country: United Kingdom
facility: NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: