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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

Primary Purpose

Alzheimer's Disease (AD)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-552
Placebo for ABBV-552
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease (AD) focused on measuring Alzheimer's disease (AD), Dementia, ABBV-552

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Irvine Clinical Research /ID# 250030Recruiting
  • Alliance for Research - Long Beach /ID# 246492Recruiting
  • Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 248891Recruiting
  • New England Institute for Clinical Research /ID# 246488Recruiting
  • Vertex Research Group Inc /ID# 248295Recruiting
  • Finlay Medical Research - West Palm Beach /ID# 246970Recruiting
  • Velocity Clinical Research - Hallandale Beach /ID# 246896Recruiting
  • New Life Medical Research Center /ID# 247536Recruiting
  • K2 Medical Research - The Villages /ID# 250820Recruiting
  • K2 Medical Research /ID# 250904Recruiting
  • Ivetmar Medical Group LLC /ID# 247670Recruiting
  • Allied Biomedical Res Inst Inc /ID# 246971Recruiting
  • New Horizon Research Center /ID# 248298Recruiting
  • K2 Medical Research - Ocoee /ID# 251029Recruiting
  • Combined Research Orlando - Phase I-IV /ID# 247697Recruiting
  • Alzheimer's Research and Treatment Center - Stuart /ID# 246484Recruiting
  • Alzheimer's Research and Treatment Center - Wellington /ID# 246491Recruiting
  • Columbus Memory Center /ID# 249534Recruiting
  • Northwest Clinical Trials /ID# 248663Recruiting
  • Allied Physicians - Fort Wayne Neurological Center /ID# 248300Recruiting
  • Josephson-Wallack-Munshower Neurology - PC /ID# 248554Recruiting
  • University of Kentucky Chandler Medical Center /ID# 251139Recruiting
  • NeuroMedical Clinic of Central Louisiana /ID# 246960Recruiting
  • Tandem Clinical Research, LLC /ID# 246973Recruiting
  • Adams Clinical /ID# 248358Recruiting
  • Velocity Clinical Research, Inc /ID# 249837Recruiting
  • American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930Recruiting
  • NeuroScience Research Center - Canton /ID# 248552Recruiting
  • Neurology Diagnostics - South /ID# 246931Recruiting
  • Summit Headlands LLC /ID# 250678Recruiting
  • Kerwin Medical Center /ID# 248662Recruiting
  • Sentara Neurology Specialists - Norfolk /ID# 248578Recruiting
  • St Vincent's Centre for Applied Medical Research /ID# 249843Recruiting
  • Box Hill Hospital /ID# 249095Recruiting
  • Australian Alzheimer's Res Fou /ID# 249097Recruiting
  • Southern Neurology /ID# 249098Recruiting
  • Universitaetsklinikum des Saarlandes /ID# 248077Recruiting
  • Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078Recruiting
  • NHO Hiroshima-Nishi Medical center /ID# 256947Recruiting
  • Kawashima Neurology Clinic /ID# 253561Recruiting
  • Shonan Kamakura General Hospital /ID# 256664Recruiting
  • Teikyo University Hospital, Mizonokuchi /ID# 253259Recruiting
  • NHO Niigata National Hospital /ID# 254207Recruiting
  • Oita University Hospital /ID# 253679Recruiting
  • Hizen Psychiatric Center /ID# 252363Recruiting
  • Juntendo University Hospital /ID# 252373Recruiting
  • CGM Research Trust /ID# 249439Recruiting
  • Hospital Universitari General de Catalunya /ID# 249100Recruiting
  • Hospital Universitario Mutua Terrassa /ID# 248448Recruiting
  • Hospital Unversitario Marques de Valdecilla /ID# 248454Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

ABBV-552 Dose A

ABBV-552 Dose B

ABBV-552 Dose C

Placebo for ABBV-552

Arm Description

Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.

Participants will receive ABBV-552 Dose B QD for 12 weeks.

Participants will receive ABBV-552 Dose C QD for 12 weeks.

Participants will receive placebo for ABBV-552 QD for 12 weeks.

Outcomes

Primary Outcome Measures

Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05771428
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
June 22, 2024 (Anticipated)
Study Completion Date
July 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD)
Keywords
Alzheimer's disease (AD), Dementia, ABBV-552

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABBV-552 Dose A
Arm Type
Experimental
Arm Description
Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.
Arm Title
ABBV-552 Dose B
Arm Type
Experimental
Arm Description
Participants will receive ABBV-552 Dose B QD for 12 weeks.
Arm Title
ABBV-552 Dose C
Arm Type
Experimental
Arm Description
Participants will receive ABBV-552 Dose C QD for 12 weeks.
Arm Title
Placebo for ABBV-552
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for ABBV-552 QD for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
ABBV-552
Intervention Description
Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo for ABBV-552
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score
Description
The ADAS-Cog was designed to assess the cognitive impairments most common in AD. The ADAS-Cog-14 includes the original 11 items from the ADAS-Cog-11 [1. Spoken language ability, 2. Comprehension of spoken language, 3. Recall of test instructions, 4. Word-findings difficulty in spontaneous speech, 5. Following commands, 6. Naming objects and fingers, 7. Constructional praxis, 8. Ideational praxis, 9. Orientation, 10. Word-recall task, 11. Word-recognition task] and includes 3 additional tasks [12. Number cancellation task, 13. Delayed word recall task, 14. Executive functioning], for increased sensitivity in mild cognitive impairment (MCI) patients. The Total Score of the ADAS-Cog-14 ranges from 0 to 90, with a higher score representing greater impairment.
Time Frame
From Baseline (Week 0) through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Irvine Clinical Research /ID# 250030
City
Irvine
State/Province
California
ZIP/Postal Code
92614
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Research - Long Beach /ID# 246492
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Name
Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 248891
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-3500
Country
United States
Individual Site Status
Recruiting
Facility Name
New England Institute for Clinical Research /ID# 246488
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905-1224
Country
United States
Individual Site Status
Recruiting
Facility Name
Vertex Research Group Inc /ID# 248295
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711-5037
Country
United States
Individual Site Status
Recruiting
Facility Name
Finlay Medical Research - West Palm Beach /ID# 246970
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467-2979
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Hallandale Beach /ID# 246896
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009-4427
Country
United States
Individual Site Status
Recruiting
Facility Name
New Life Medical Research Center /ID# 247536
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-4654
Country
United States
Individual Site Status
Recruiting
Facility Name
K2 Medical Research - The Villages /ID# 250820
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159-8975
Country
United States
Individual Site Status
Recruiting
Facility Name
K2 Medical Research /ID# 250904
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-5669
Country
United States
Individual Site Status
Recruiting
Facility Name
Ivetmar Medical Group LLC /ID# 247670
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-6542
Country
United States
Individual Site Status
Recruiting
Facility Name
Allied Biomedical Res Inst Inc /ID# 246971
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
New Horizon Research Center /ID# 248298
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-3372
Country
United States
Individual Site Status
Recruiting
Facility Name
K2 Medical Research - Ocoee /ID# 251029
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761-4547
Country
United States
Individual Site Status
Recruiting
Facility Name
Combined Research Orlando - Phase I-IV /ID# 247697
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Name
Alzheimer's Research and Treatment Center - Stuart /ID# 246484
City
Stuart
State/Province
Florida
ZIP/Postal Code
34997-5765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
561-209-2400
Facility Name
Alzheimer's Research and Treatment Center - Wellington /ID# 246491
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Memory Center /ID# 249534
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909-1693
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Trials /ID# 248663
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Name
Allied Physicians - Fort Wayne Neurological Center /ID# 248300
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
Josephson-Wallack-Munshower Neurology - PC /ID# 248554
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256-4692
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
317-537-6064
Facility Name
University of Kentucky Chandler Medical Center /ID# 251139
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroMedical Clinic of Central Louisiana /ID# 246960
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301-3900
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research, LLC /ID# 246973
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072-3156
Country
United States
Individual Site Status
Recruiting
Facility Name
Adams Clinical /ID# 248358
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
1-617-744-8542
Facility Name
Velocity Clinical Research, Inc /ID# 249837
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Name
American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45432-2886
Country
United States
Individual Site Status
Recruiting
Facility Name
NeuroScience Research Center - Canton /ID# 248552
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718-2784
Country
United States
Individual Site Status
Recruiting
Facility Name
Neurology Diagnostics - South /ID# 246931
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459-4296
Country
United States
Individual Site Status
Recruiting
Facility Name
Summit Headlands LLC /ID# 250678
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Kerwin Medical Center /ID# 248662
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4316
Country
United States
Individual Site Status
Recruiting
Facility Name
Sentara Neurology Specialists - Norfolk /ID# 248578
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510-1065
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincent's Centre for Applied Medical Research /ID# 249843
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Box Hill Hospital /ID# 249095
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Australian Alzheimer's Res Fou /ID# 249097
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Southern Neurology /ID# 249098
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum des Saarlandes /ID# 248077
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66424
Country
Germany
Individual Site Status
Recruiting
Facility Name
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
NHO Hiroshima-Nishi Medical center /ID# 256947
City
Otake-shi
State/Province
Hiroshima
ZIP/Postal Code
739-0696
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kawashima Neurology Clinic /ID# 253561
City
Fujisawa-shi
State/Province
Kanagawa
ZIP/Postal Code
251-0038
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shonan Kamakura General Hospital /ID# 256664
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
Teikyo University Hospital, Mizonokuchi /ID# 253259
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
NHO Niigata National Hospital /ID# 254207
City
Kashiwazaki-shi
State/Province
Niigata
ZIP/Postal Code
945-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Oita University Hospital /ID# 253679
City
Yufu-shi
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hizen Psychiatric Center /ID# 252363
City
Kanzaki-gun
State/Province
Saga
ZIP/Postal Code
842-0192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Juntendo University Hospital /ID# 252373
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
CGM Research Trust /ID# 249439
City
Christchurch Central
ZIP/Postal Code
8011
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
6433656777
Facility Name
Hospital Universitari General de Catalunya /ID# 249100
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Mutua Terrassa /ID# 248448
City
Terrasa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Unversitario Marques de Valdecilla /ID# 248454
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-515
Description
Related Info

Learn more about this trial

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

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