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 Trials | Recruiting
The Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Amyloid Removal Trial (ART): A Phase IIIb/IV Open-Label Study of Lecanemab to Evaluate Prevention and Progression of Dominantly Inherited Alzheimer’s Disease
An open label study to treat dominantly inherited Alzheimer’s disease (DIAD) mutation carrier participants from the DIAN-TU-001 gantenerumab Open Label Extension (OLE) period with lecanemab to determine the effects of amyloid removal on age of onset and clinical progression compared to external controls, if amyloid plaque as measured by amyloid PET can be fully removed in DIAD, and the effects of amyloid removal on biomarkers of disease progression.
Type of Study: Experimental medicine (lecanemab). This study will be offered to participants having participated in the DIAN-TU-001 gantenerumab OLE period. Starting at Week 0, participants will receive open-label lecanemab administered intravenously approximately every 2 weeks for a minimum of 5 years utilizing a common close design.
Who can participate? Participants who previously participated in DIAN-TU-001 gantenerumab OLE period. Participants must be co-enrolled in the DIAN Observational Study (DIAN Obs, NCT00869817) and be willing to complete DIAN Obs procedures and assessments.
What are the study procedures? MRI’s, IV infusions, blood and urine tests, vital signs video conferences/phone calls, etc. through the DIAN-ART study; ECG, PET scans, pen and paper tests, questionnaires, blood and urine tests, collection of vital signs, physical/neurological exams, video conferences/phone calls, lumbar punctures through the DIAN-Obs study (co-enrollment in both studies is required)
How long is participation? Participants will participate in this study for about a minimum of 5 years.
Is there compensation: Yes
Synaptic Therapy Alzheimer’s Research Trial (START): A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety and Efficacy of CT1812 in Early Alzheimer’s Disease over 18 Months
A study designed to evaluate the efficacy, safety, and tolerability of two doses of CT1812 compared to placebo in participants diagnosed with early Alzheimer’s disease.
Type of Study: Investigational medicine (or placebo). Participants will have to take the oral study drug or placebo once per day for 18 months.
Who can participate? Individuals ages 50-85 years old who have a diagnosis of either mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia, OR memory concerns noticed by another person.
What are the study procedures? MRI’s, ECG, PET scans, pen and paper tests, questionnaires, blood and urine tests, collection of vital signs, physical/neurological exams, video conferences/phone calls, optional lumbar punctures
How long is participation? Participants will participate in this study for about 2 years and will be asked to make about 24 visits to the study site to see doctors who will closely monitor their health.
Is there compensation: Yes
Is there compensation: Yes, if blood sample is provided.
Active Trials | Not Recruiting
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
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
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.
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