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INFORMATION FOR

Clinical Trials

October 2021

Here is a brief synopsis of clinical research studies available in the Alzheimer’s Disease Research Unit. Please call us at (203) 764-8100 if you would like more information about any of these studies. Please call us at (203) 764-8100 if you would like more information about any of these studies. Interested patients/caregivers are also more than welcome to call us if they are interested in participating in any of our research studies or would like more information.

Caregiver Support Group

In addition to our clinical research studies, we offer a free monthly support group for caregivers of AD patients, whether or not they are participating in our research studies. Interested caregivers can call (203) 764-8100 and ask for Susan.

Treatment Studies

Enrolling

BAN2401 for Individuals at Risk for Alzheimer’s Dementia (A3-45 Study)

A stage of “preclinical Alzheimer’s disease” has recently been defined based on biomarker evidence of amyloid-β pathology before the stage of clinical symptoms. Clinically “normal” older individuals with elevated Aβ pathology (by PET scan) are at increased risk for cognitive decline and progression to Alzheimer’s dementia. BAN2401 is a humanized monoclonal antibody with high selectivity for soluble amyloid-β protofibrils. This is a 4-year, double-blind, placebo-controlled, phase 3 study to evaluate the safety, tolerability, and efficacy of BAN2401 in cognitively normal participants ages 55-80 years who are at risk of developing Alzheimer’s dementia. Participants with intermediate (A3 study) or elevated (A45 study) levels of brain amyloid on a screening PET scan will be randomized to receive intravenous BAN2401 or placebo (50% probability of receiving active BAN2401). A3 study participants will receive BAN2401 (titrated up to 10mg/kg) or placebo every four weeks. A45 study participants will receive BAN2401 (titrated up to 10mg/kg) or placebo every 2 weeks for the first 96 weeks, then every four weeks for the remainder of the study. Participants will be required to have at least 12 MRI scans, three amyloid (18F-NAV4694) PET scans, and three tau (18F-MK6240) PET scans. Participants can also participate in an optional lumbar puncture substudy. Does NOT permit concurrent treatment with cholinesterase inhibitors and memantine. HIC#2000027712.

JNJ-63733657 for Prodromal or Mild Alzheimer’s Disease.

JNJ-63733657 is a monoclonal antibody directed against extracellular tau protein, thereby slowing the toxic spread of this protein in Alzheimer’s disease. This phase 2 study will evaluate the safety, tolerability, and efficacy of JNJ-63733657 in participants ages 55-80 years with prodromal or mild Alzheimer’s disease for 128 weeks. Participants will be randomized to receive study drug (1000 mg or 3000 mg) or placebo that will be administered intravenously (67% probability of receiving active JNJ-63733657). Infusions will occur every 4 weeks. Participants will have up to 6 brain MRI scans, up to 3 Tau PET scans, and up to 3 optional lumbar punctures with study participation. After completing the double-blind study, participants may have the option of continuing in a long-term extension study in which all subjects will receive JNJ-63733657. Permits concurrent treatment with cholinesterase inhibitors and/or memantine, providing they have been on it for at least 4 months and on a stable dose at least 2 months prior to screening. HIC# 2000029685.

CVL-871 for the Treatment of Dementia-Related Apathy

Apathy is among the most prevalent and disabling neuropsychiatric symptoms in individuals with dementia. CVL-871 is a dopamine D1/D5 receptor partial agonist that may normalize impaired dopamine signaling in brain regions that control reward and motivation and thus be useful for the treatment of apathy. This is a Phase 2a, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacodynamics of CVL-871 in individuals with dementia-related apathy. Participants will be randomly assigned in a 1:1:1 ratio to receive oral CVL-871 1.0mg, CVL-871 3.0mg, or placebo, once daily for 12 weeks (67% chance of receiving active study drug). Permits concurrent treatment with cholinesterase inhibitors and memantine. HIC# 2000303951.

Closed to Enrollment

BAN2401 for Prodromal or Mild Alzheimer’s Disease
BAN2401 is a humanized monoclonal antibody with high selectivity for soluble amyloid-β protofibrils. This is a Phase 3, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of BAN2401 in participants ages 50-90 years with early (prodromal or mild) Alzheimer’s disease. Participants will be randomized to receive BAN2401 (10 mg/kg) or placebo that will be administered intravenously (50% probability of receiving active BAN2401). Participants will have up to 7 brain MRI scans and up to 2 18F-florbetaben PET scans or 1 lumbar puncture. Additionally, participants will have the option of participating in 7 additional PET scans (4 18F-florbetaben and 3 18F-MK-6240) and 2 additional lumbar punctures provided with study participation. Finally, participants who complete the double-blind phase will have the option of participating in a 2-year study extension in which all participants will receive BAN2401. Permits concurrent treatment with cholinesterase inhibitors and/or memantine, providing they have been on a stable dose at least 4 weeks prior to screening. (MMSE ≥22). HIC#2000026162

Donanemab for Prodromal or Mild Alzheimer’s Disease
Donanemab is an antibody directed at the pyroglutamate modification of the third amino acid of amyloid beta (N3pG Aβ) epitope that is present only in brain amyloid plaques. This is a Phase 2, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and efficacy of donanemab in participants ages 60-85 years with prodromal or mild Alzheimer’s disease. Participants will be randomized to receive donanemab (1400 mg) or placebo that will be administered intravenously (50% probability of receiving active donanemab). Participants will have up to five brain MRI scans, up to four 18F-florbetapir PET scans, and two 18F-flortaucipir PET scans. Permits concurrent treatment with cholinesterase inhibitors and/or memantine, providing they have been on a stable dose at least 4 weeks prior to baseline. (MMSE ≥20). HIC#2000028807

Gantenerumab for Prodromal or Mild Alzheimer’s Disease
Gantenerumab is a monoclonal antibody that is directed against the amyloid-β protein. This is a 2-year, double-blind, placebo-controlled, phase 3 study designed to evaluate the efficacy and safety of gantenerumab in individuals with early (prodromal to mild) Alzheimer’s disease. Subjects will be randomized to receive gantenerumab (titrated up to 510mg) or placebo as a subcutaneous (SC) injection every 4 weeks for at least the first 9 months, and then every 2 weeks for the remaining duration (up to a total of 43 dosing visits). Subjects will be randomized in a 1:1 ratio to receive gantenerumab or placebo (50% probability of receiving active drug). Subjects will be required to have at least 8 MRI scans, and either an amyloid (florbetaben) PET scan or lumbar puncture provided with study participation. Subjects can also participate in optional amyloid (florbetaben) and/or tau (GTP1) PET substudies. Permits concurrent treatment with cholinesterase inhibitors and memantine. HIC#2000021691

Aducanumab for Early Alzheimer’s Disease
Aducanumab is a human monoclonal antibody that is administered by intravenous infusion and is directed against the amyloid-β protein. This is a 2-year, placebo-controlled, Phase 3 study designed to evaluate the safety and efficacy of aducanumab in individuals with early Alzheimer’s disease (33 clinic visits). Participants will be randomized to receive study drug or placebo that will be administered by intravenous infusion once four weeks (20 infusions; 67% probability of receiving active study medication). Subjects will have 8 brain MRI scans and one PET scan provided with study participation. Subjects may also participate in an optional PET substudy and an optional cerebrospinal fluid substudy. After the 2-year placebo-controlled period, participants will have the option of entering a 2-year long-term extension of the study. Permits concurrent treatment with cholinesterase inhibitors and/or memantine. (MMSE 24-30, inclusive). HIC#1505015817

Solanezumab for Individuals at Risk for Alzheimer’s Disease [“A4”]
A stage of “preclinical Alzheimer’s disease” has recently been defined based on biomarker evidence of amyloid-β pathology before the stage of clinical symptoms. Clinically “normal” older individuals with elevated Aβ pathology (by PET scan) are at increased risk for cognitive decline and progression to Alzheimer’s dementia. Solanezumab (LY2062430) is an anti-AB IgG1 monoclonal antibody that is directed against the amyloid-β protein. This is a 3-year, placebo-controlled, Phase 3 study designed to test the hypothesis that Solanezumab will slow cognitive decline in individuals with preclinical Alzheimer’s disease. Subjects will receive Solanezumab 400 mg or placebo as an intravenous (IV) infusion once every 4 weeks (50% probability of receiving active study medication). Subjects who complete this study may be eligible to receive Solanezumab as part of an additional open-label extension study. Subjects will be required to have 4 brain MRI scans and 2 florbetapir PET scans provided with study participation. Subjects can also participate in 2 optional lumbar punctures during the study. HIC#1311013008

BMS-984923 in Healthy Participants
BMS-984923 is an oral compound that blocks amyloid beta activation of mGluR5 and may recover synapse loss in Alzheimer’s disease. This is a Phase 1a study to evaluate the safety and tolerability of BMS-984923 in healthy participants before the drug is studied in patients with Alzheimer’s disease. Participants are between the ages of 50 and 80. The study procedures include medical history and physical exam, blood and urine samples, memory testing, a single oral dose of study drug, a 48-hour hospital visit for safety monitoring, close follow up for a period of 7 days after taking the study drug, and possible enrollment in a sub-study with one MRI and up to three PET scans. Length of participation is approximately 14 weeks. Participants will be compensated up to $1925 for their time. HIC#2000028864

Aerobic Exercise for Mild Cognitive Impairment
This is an 18-month, Phase 3, randomized study designed to evaluate the efficacy of aerobic exercise in individuals with mild cognitive impairment (5 clinic visits). Participants will be randomized to moderate/high intensity aerobic training or stretching/balance/range of motion training (50% probability of being assigned to each training condition). Subjects will exercise at local YMCAs four (4) times per week for 18 months. During the first 12 months of the study, two of the four weekly sessions will be supervised by a study-certified YMCA trainer. In the final 6 months, participants will continue to complete their assigned exercise program at the YMCA without supervision. Subjects will have two (2) brain MRI scans provided with study participation. Subjects may also participate in an optional cerebrospinal fluid substudy (2 lumbar punctures). Permits concurrent treatment with cholinesterase inhibitors. (MMSE ≥ 24). HIC#1605017787