Alzheimer's Disease (AD) Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | October 28, 2024 |
| Est. primary completion date | June 22, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 90 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Box Hill Hospital /ID# 249095 | Box Hill | Victoria |
| Australia | St Vincent's Centre for Applied Medical Research /ID# 249843 | Darlinghurst | New South Wales |
| Australia | Southern Neurology - Kogarah /ID# 249098 | Kogarah | New South Wales |
| Australia | Australian Alzheimer's Res Fou /ID# 249097 | Nedlands | Western Australia |
| Germany | Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 248078 | Berlin | |
| Germany | Universitaetsklinikum des Saarlandes /ID# 248077 | Homburg | |
| Japan | Juntendo University Hospital /ID# 252373 | Bunkyo-ku | Tokyo |
| Japan | Kawashima Neurology Clinic /ID# 253561 | Fujisawa-shi | Kanagawa |
| Japan | Shonan Kamakura General Hospital /ID# 256664 | Kamakura-shi | Kanagawa |
| Japan | Hizen Psychiatric Center /ID# 252363 | Kanzaki-gun | Saga |
| Japan | Nara Medical University Hospital /ID# 252564 | Kashihara-shi | Nara |
| Japan | NHO Niigata National Hospital /ID# 254207 | Kashiwazaki-shi | Niigata |
| Japan | Teikyo University Mizonokuchi Hospital /ID# 253259 | Kawasaki | Kanagawa |
| Japan | NHO Hiroshima-Nishi Medical center /ID# 256947 | Otake-shi | Hiroshima |
| Japan | Oita University Hospital /ID# 253679 | Yufu City | Oita |
| New Zealand | CGM Research Trust /ID# 249439 | Christchurch Central | |
| Spain | Hospital Internacional Ruber - Grupo Quiron Salud /ID# 248856 | Madrid | |
| Spain | CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 248415 | Pamplona | Navarra |
| Spain | Hospital Universitario de Salamanca /ID# 249101 | Salamanca | |
| Spain | Hospital Universitari General de Catalunya /ID# 249100 | Sant Cugat del Vallès | Barcelona |
| Spain | Hospital Universitario Marques de Valdecilla /ID# 248454 | Santander | Cantabria |
| Spain | Hospital Universitario Mutua Terrassa /ID# 248448 | Terrasa | Barcelona |
| United Kingdom | Re:Cognition Health Birmingham /ID# 249796 | Birmingham | |
| United Kingdom | Re:Cognition Health Bristol /ID# 249795 | Bristol | Bristol, City Of |
| United Kingdom | Re:Cognition Health - London /ID# 249005 | London | |
| United Kingdom | St Pancras Clinical Research /ID# 249006 | London | |
| United Kingdom | NeuroClin Limited(Previously Glasgow Memory Clinic) /ID# 249787 | Motherwell | |
| United States | NeuroMedical Clinic of Central Louisiana /ID# 246960 | Alexandria | Louisiana |
| United States | American Clinical Research Institute (ACRI) - Beavercreek /ID# 246930 | Beavercreek | Ohio |
| United States | Northwest Clinical Trials /ID# 248663 | Boise | Idaho |
| United States | NeuroScience Research Center - Canton /ID# 248552 | Canton | Ohio |
| United States | Vertex Research Group Inc /ID# 248295 | Clermont | Florida |
| United States | Columbus Memory Center /ID# 249534 | Columbus | Georgia |
| United States | Kerwin Medical Center /ID# 248662 | Dallas | Texas |
| United States | Neurology Diagnostics - South /ID# 246931 | Dayton | Ohio |
| United States | ANESC Research /ID# 246958 | El Paso | Texas |
| United States | Allied Physicians - Fort Wayne Neurological Center /ID# 248300 | Fort Wayne | Indiana |
| United States | Finlay Medical Research - West Palm Beach /ID# 246970 | Greenacres City | Florida |
| United States | Velocity Clinical Research - Hallandale Beach /ID# 246896 | Hallandale Beach | Florida |
| United States | New Life Medical Research Center - Hialeah /ID# 247536 | Hialeah | Florida |
| United States | Josephson-Wallack-Munshower Neurology - Northeast /ID# 248554 | Indianapolis | Indiana |
| United States | Irvine Clinical Research /ID# 250030 | Irvine | California |
| United States | K2 Medical Research - The Villages /ID# 250820 | Lady Lake | Florida |
| United States | University of Kentucky - Sanders Brown Center on Aging /ID# 251139 | Lexington | Kentucky |
| United States | Alliance for Research - Long Beach /ID# 246492 | Long Beach | California |
| United States | Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 248891 | Los Alamitos | California |
| United States | K2 Medical Research /ID# 250904 | Maitland | Florida |
| United States | Tandem Clinical Research, LLC /ID# 246973 | Marrero | Louisiana |
| United States | Allied Biomedical Res Inst Inc /ID# 246971 | Miami | Florida |
| United States | Ivetmar Medical Group /ID# 247670 | Miami | Florida |
| United States | New Horizon Research Center /ID# 248298 | Miami | Florida |
| United States | Vanderbilt Ingram Cancer Center /ID# 248801 | Nashville | Tennessee |
| United States | Sentara Neurology Specialists - Norfolk /ID# 248578 | Norfolk | Virginia |
| United States | K2 Medical Research - Ocoee /ID# 251029 | Ocoee | Florida |
| United States | Health Synergy Clinical Research LLC /ID# 247726 | Okeechobee | Florida |
| United States | Combined Research Orlando - Phase I-IV /ID# 247697 | Orlando | Florida |
| United States | Summit Headlands LLC /ID# 250678 | Portland | Oregon |
| United States | Velocity Clinical Research, Inc /ID# 249837 | Raleigh | North Carolina |
| United States | Epic Medical Research /ID# 249141 | Red Oak | Texas |
| United States | New England Institute for Clinical Research /ID# 246488 | Stamford | Connecticut |
| United States | Alzheimer's Research and Treatment Center - Stuart /ID# 246484 | Stuart | Florida |
| United States | Adams Clinical /ID# 248358 | Watertown | Massachusetts |
| United States | Alzheimer's Research and Treatment Center - Wellington /ID# 246491 | Wellington | Florida |
| United States | Conquest Research /ID# 262078 | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
United States, Australia, Germany, Japan, New Zealand, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | From Baseline (Week 0) through Week 12 |
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