Active Trials (Not Recruiting)
Interventional Studies
Study Title: A Study of JNJ-63733657 in Participants With Early Alzheimer's Disease (Autonomy)
Purpose
The Autonomy Study will see if the investigational medicine may stop abnormal tau from spreading in the brain, and slow memory loss. Tau is a protein found in the brain. In people with AD, an abnormal form of tau builds up in the brain and may cause memory loss. If a potential participant meets all study eligibility criteria, the presence of abnormal tau in their brain will be evaluated. The Autonomy Study will include about 420 participants. Each participant could be in the study for up to 5 years; however, most participants will be in the study for 3 years or less. The study will involve up to 65 visits to the study center. In this study, the investigational medicine is being compared with a placebo. A placebo looks just like the investigational medicine and is given in the same way, but it does not contain any active ingredients. Participants will receive either the investigational medicine or the placebo every 4 weeks.
Anyone interested may be able to take part if they:
- are 55–80 years of age
- are experiencing a gradual decline in their cognitive abilities (e.g. memory, problem-solving skills, and ability to pay attention and think clearly) over at least the past 6 months or have been diagnosed with early AD
- have a reliable close friend, relative, or spouse who can be their study partner. This should be someone who spends at least 10 hours every week with them, knows their daily functioning well, and is able to accompany them to visits to the study center.
(PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Development Program)
Contact: Lauren Garcia at (310) 794-6191 or send an email to LAGarcia@mednet.ucla.edu for more information.
Sponsor: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04619420
Condition: Alzheimer's Disease, Cognitive Dysfunction, and Dementia
Study Type: Interventional (Clinical Trial)
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease
Source: ClinicalTrials.gov
Study Title: Confirm Safety and Efficacy of BAN2401 Anti-Amyloid-beta Immunotherapy in Participants With Early Alzheimer's Disease (Clarity AD)
Purpose
The Kagan Clinical Trial Program is conducting an Eisai funded study called BAN2401 anti-amyloid-beta. The primary objective is to evaluate the efficacy of BAN2401 anti-amyloid-beta, investigational agent in subjects with early Alzheimer’s disease (EAD) compared to Placebo. The key measure used to determine if BAN2401 anti-amyloid-beta compared with placebo is the Clinical Dementia Rating–Sum of Boxes (CDR-SB) which will be used to compare change of scores from baseline to the 18-month time point. Participants will undergo an hour-long infusion every 2 weeks along with neuropsychological assessments, MRI and PETs at various time points throughout the study. The study is free and voluntary. It is approximately 18 months long, with up to 5 visits within the first 90 days of screen. This study does have an extension phase for up to 2 years after the initial 18 months have been completed or until commercial availability of BAN2401 anti-amyloid-beta or until a positive risk benefit assessment in this indication is not demonstrated. Enrollment is open to patients with a diagnosis of Mild Alzheimer’s disease or Mild Cognitive Impairment due to AD who are between the ages of 50 and 90 years old. (PI: Maryam Beigi, MD, Easton Center's Katherine and Benjamin Kagan Alzheimer's Disease Treatment Development Program)
Contact: Lauren Garcia at (310) 794-6191 or send an email to LAGarcia@mednet.ucla.edu for more information.
Sponsor: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03887455
Condition: Early Alzheimer's Disease
Study Type: Interventional (Clinical Trial)
Study Design:
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Source: ClinicalTrials.gov
Ages Eligible for Study: 50 Years to 90 Years (Adult, Older Adult)
Genders Eligible for Study: All