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Oral ABBV-552 for Alzheimer's Disease

Verified Trial
Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) through week 12
Awards & highlights

Study Summary

This trial is testing an experimental drug to treat Alzheimer's disease. 240 people aged 50-90 with mild Alzheimer's will take it orally once daily and be monitored.

Who is the study for?
This trial is for people aged 50 to 90 with mild Alzheimer's Disease, as defined by specific criteria including certain scores on memory and cognitive tests. Those with significant unstable medical conditions or factors that may affect study participation are excluded.Check my eligibility
What is being tested?
The trial is testing ABBV-552, a new drug for early Alzheimer's symptoms. Participants will be randomly assigned to one of four groups, three receiving different doses of the drug and one receiving a placebo, over a period of 12 weeks.See study design
What are the potential side effects?
Potential side effects include reactions related to the nervous system changes due to Alzheimer’s treatment but specifics aren't provided. Regular check-ups will monitor any adverse events from taking ABBV-552.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) through week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) through week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 14) score

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: ABBV-552 Dose CExperimental Treatment1 Intervention
Participants will receive ABBV-552 Dose C QD for 12 weeks.
Group II: ABBV-552 Dose BExperimental Treatment1 Intervention
Participants will receive ABBV-552 Dose B QD for 12 weeks.
Group III: ABBV-552 Dose AExperimental Treatment1 Intervention
Participants will receive ABBV-552 Dose A once daily (QD) for 12 weeks.
Group IV: Placebo for ABBV-552Placebo Group1 Intervention
Participants will receive placebo for ABBV-552 QD for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABBV-552
2023
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
958 Previous Clinical Trials
502,150 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
146,869 Total Patients Enrolled

Media Library

ABBV-552 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05771428 — Phase 2
Alzheimer's Disease Research Study Groups: ABBV-552 Dose A, ABBV-552 Dose B, ABBV-552 Dose C, Placebo for ABBV-552
Alzheimer's Disease Clinical Trial 2023: ABBV-552 Highlights & Side Effects. Trial Name: NCT05771428 — Phase 2
ABBV-552 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05771428 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with administering ABBV-552 Dose A to patients?

"As ABBV-552 Dose A is currently in Phase 2 of trials, our team at Power has assigned it a safety rating of 2. Meaning, while there are some data points supporting its security profile, none have been found that support efficacy."

Answered by AI

Who is eligible to volunteer for this research endeavor?

"This clinical trial is enlisting individuals diagnosed with Alzheimer's disease that are aged between 50 and 90. It hopes to recruit up to 240 volunteers for the study."

Answered by AI

Is eligibility for this research study being extended to individuals of advanced age?

"This clinical trial has established a minimum age limit of 50 and an upper boundary of 90 for potential participants."

Answered by AI

Is this research currently recruiting participants?

"Clinicaltrials.gov confirms that this study, which was initially published on April 2nd 2023 and most recently edited on March 6th 2023, is not presently searching for participants. However, there are 540 other clinical trials in need of patients at the moment."

Answered by AI

How many venues are presently hosting this experimental research?

"For this clinical trial, 60 sites are operating such as Alliance for Research in Long Beach (ID# 246492), Pharmacology Research Institute (PRI) located in Los Alamitos (Wake) (ID# 248891), and Artemis Institute for Clinical Research based out of Riverside (ID# 250677). Other locations are also included."

Answered by AI

Who else is applying?

What site did they apply to?
ClinCloud, Maitland
NeuroScience Research Center - Canton /ID# 248552
Tandem Clinical Research - New York, NY
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Tandem Clinical Research - New York, NY: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05771428.
All > Alzheimers Disease Dallas > Meridian
~18 spots leftby Jun 2024
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