The Knight ADRC Clinical Trials Unit is currently participating in the clinical trials below. By clicking each trial’s Learn More button, you will be taken to ClinicalTrials.gov to learn more about that trial’s details including eligibility criteria. Contact us if you would like to learn more about participating in one of the active and recruiting trials below.
Active | Recruiting Trials
AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel-Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial)and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)
A study to determine whether treatment with the study drug lecanemab (BAN2401), is safe and effective in preventing or delaying the onset of Alzheimer’s disease in individuals with higher risk for developing the disease.
Type of Study: Investigational medicine (chance of placebo); once or twice-a-month intravenous (IV) infusions
Who can participate? Individuals age 55-80 years old who have risk factors for Alzheimer’s disease but have not been diagnosed with Alzheimer’s disease
What are the study procedures? MRI’s, PET scans, pen and paper tests, questionnaires, blood and urine tests, infusions, physical/neurological exams, optional lumbar puncture
How long is participation? 4 1/2 years, involving in-person and telephone visits with study researchers every two to four weeks
Is there compensation? Yes
Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer’s Disease Caused by a Genetic Mutation (DIAN-TU NexGen Trial)
A study to evaluate the safety, tolerability, and efficacy of the investigational therapies lecanemab and E2814, based on biomarkers and cognitive measures, in people who know they have an Alzheimer’s disease-causing mutation, and are with or without symptoms.
Type of Study: Investigational medicine (chance of placebo). Symptomatic participants will be administered lecanemab for six months before being randomly assigned to also receive the anti-tau drug E2814 or a placebo. Pre-symptomatic participants will be randomly assigned to receive the anti-tau drug E2814 or a placebo for a year before beginning lecanemab administration
Who can participate? Individuals ages 18-80 years old who know they have an Alzheimer’s disease-causing mutation (or are willing to learn genetic status before enrollment), and are within -10 to +10 years of the predicted (based on parent’s actual age at onset) or actual age of cognitive symptom onset. Can either not be diagnosed with Alzheimer’s disease (pre-symptomatic) or diagnosed with Early to Mild Alzheimer’s disease (symptomatic)
What are the study procedures? MRI’s, ECG, PET scans, pen and paper tests, questionnaires, blood and urine tests, lumbar punctures, infusions, collection of vital signs, physical/neurological exams, video conferences/phone calls
How long is participation? Participants will participate in this study for a minimum of 208 weeks (4 years) and a maximum of 364 weeks (about 7 years). All participants will continue dosing until the last concurrently enrolled participant(s) reaches 4 years of study treatment.
Is there compensation: Yes
New IDEAS: Imaging Dementia—Evidence for Amyloid Scanning Study: A Study to Improve Precision in Amyloid PET Coverage and Patient Care
New IDEAS examines how PET amyloid scanning, a kind of brain scan, can help physicians to diagnose and treat Alzheimer’s and other forms of dementia. It will also examine biomarkers, which are changes that a disease might cause in the body that doctors can measure with tests like blood tests. Identifying biomarkers can help to diagnose or treat the disease. At least 4,000 of the projected 7,000 New IDEAS participants will be Black or African American and Hispanic or Latino. Historically, Blacks and Hispanics haven’t been represented fully in Alzheimer’s and dementia clinical studies. This study seeks to ensure that the results represent all racial and ethnic groups and thus will examine brain amyloid positron emission tomography (PET) scans in diverse populations with early to mild Alzheimer’s disease and dementia.
Type of Study: Observational (no treatment)
Who can participate? Participants must meet the criteria for early to mild Alzheimer’s disease or dementia due to Alzheimer’s.
Currently, enrollment is limited to minoritized populations only (African-American, Hispanic/Latinx, Asians, Pacific Islanders, Indigenous populations, etc).
What are the study procedures? You would visit one of the participating doctors, have a PET amyloid scan and three months later, a follow-up visit with the doctor. You will receive in the mail a kit to collect saliva for a saliva test and will mail the kit back. You can also choose to give a blood sample.
How long is participation? The process takes approximately three to six months.
Is there compensation: Yes, if blood sample is provided.
TRC-PAD Program: In-Clinic Trial-Ready Cohort
This is study is designed to create a group of cognitively healthy volunteers willing to participate in clinical trials aimed at discovering treatments that will reduce the risk of developing Alzheimer’s dementia. This study will also help researchers enroll participants into these trials quickly. To join the TRC-PAD study, individuals must first complete an Alzheimer Prevention Trials (APT) webstudy online questionnaire and memory tests at https://www.aptwebstudy.org/. If selected, participants will make an in-person visit to a study site, where they will complete several assessments to see if they qualify to join the cohort.
Type of Study: Observational (no treatment)
Who can participate? Healthy adults over the age of 50 must first enroll in the APT Webstudy to potentially be invited to a research clinic for an in-person evaluation to determine TRC eligibility. APT Webstudy volunteers with slight changes in memory over time or other characteristics deemed important to Alzheimer’s research (e.g., family history, age, memory loss) may be invited to a no cost, in-person evaluation at a research clinic near them to be evaluated for the TRC.
What are the study procedures? PET scans, optional lumbar punctures, pen and paper tests, questionnaires, genetic testing, blood and urine tests, collection of vital signs, physical/neurological exams
How long is participation? There is no current end date to the TRC. Cohort volunteers will be assessed in-person two times each year at a research clinic near them. During these assessments, researchers will administer different tests to measure memory changes and other indicators of Alzheimer’s disease. If changes are noticed that align with Alzheimer’s studies enrolling volunteers, or if new studies begin that fit already followed members of the cohort, volunteers will be invited to join an Alzheimer’s therapeutic trial if they choose.
Is there compensation? Yes
Active | Not Recruiting
The primary objective is to evaluate the long-term safety and tolerability of aducanumab after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).
This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer’s disease (EAD) by determining the superiority of BAN2401 compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of BAN2401 in participants with EAD in the Extension Phase and whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.
The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).
The main goals of this study are to further determine whether the study drug donanemab is safe and effective in participants with Alzheimer’s disease and to validate video scale assessments.
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 (AUTONOMY)
A study to determine whether treatment with the study drug JNJ-63733657 is safe and effective for individuals with early Alzheimer’s disease.
Type of Study: Investigational medicine (chance of placebo); once-a-month intravenous (IV) infusions
Who can participate? Individuals age 55-80 years old who 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 (also known as mild cognitive impairment due to AD, prodromal AD, or mild AD dementia)
What are the study procedures? MRI’s, ECG, PET scans, pen and paper tests, questionnaires, blood and urine tests, infusions, collection of vital signs, physical/neurological exams
How long is participation? 5 years, including a 3 month screening period, 4.5 year treatment period, and 3 month follow-up period
Is there compensation? Yes