A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease
A Master Protocol for Phase 1 Clinical Trials of Multiple Amyloid-Targeting Therapies for the Treatment of Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of several drugs and how well people can handle their side effects. It includes healthy adults and adults with Alzheimer's disease. It also tests whether the drugs remove amyloid plaques, or protein clumps, from the brains of people with Alzheimer's.
The purpose of this Master Protocol is to support multiple studies looking at safety and tolerability of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease. Participants will enroll into either A1D-MC-AT01 (NCT07787182) or A1D-MC-AT02 (upcoming).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Healthy adults: Must be ages 18–45 and have a body mass index (BMI), a measure of weight compared with height, of 18–32.
- Healthy adults: Must be healthy based on a medical history, physical exam, and heart rhythm tests.
- Adults with Alzheimer's: Must be ages 55–85.
- Adults with Alzheimer's: Must have memory problems that have slowly worsened for at least 6 months, plus a diagnosis of mild thinking problems due to Alzheimer's or mild-to-moderate Alzheimer's dementia.
- Adults with Alzheimer's: Must score at least 16 on the Mini-Mental State Exam, a memory and thinking test.
- Adults with Alzheimer's: Must have a PET brain scan showing amyloid protein clumps.
- Adults with Alzheimer's: Must have a reliable study partner who is in frequent contact and agrees in writing to take part. A backup partner is allowed.
- Adults with Alzheimer's: If taking medicines for Alzheimer's symptoms, doses must be stable for at least 8 weeks before study treatment is assigned and be planned to stay stable.
Who can't join
- All adults: Certain serious or unstable brain or mental health conditions, or major heart, lung, liver, kidney, digestive, hormone, blood, or nerve diseases. Alzheimer's is allowed in the Alzheimer's group.
- All adults: Allergies to monoclonal antibodies (a type of medicine), diphenhydramine, epinephrine, or methylprednisolone; or multiple or severe drug allergies or severe allergic reactions after treatment.
- All adults: Cancer within the past 5 years. Some early skin cancers are allowed if removed and there has been no sign of spread for 3 years.
- All adults: Past treatment targeting amyloid or a vaccine against amyloid beta; or receiving an active study treatment in a drug trial within the past 30 days.
- All adults: Pregnancy, breastfeeding, or plans for either during the study; abnormal blood pressure or pulse as judged by the study doctor; or a history of high blood pressure.
- Healthy adults: Important brain MRI findings that could make the study unsafe; or back problems, back injuries, or an infection that could make a spinal tap difficult or unsafe. A spinal tap collects fluid from the lower back.
- Healthy adults: A family history of Alzheimer's diagnosed before age 65.
- Adults with Alzheimer's: Cannot safely have or tolerate an MRI, or cannot safely have an amyloid PET scan. Certain MRI findings also rule people out, including brain swelling, bleeding, strokes, severe damage to brain white matter, or signs of another cause of dementia.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll. Inclusion Criteria for Healthy Participants: * Are between 18 and 45 years of age * Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²) * Are overtly healthy as determined by medical evaluation, including medical history, physical examination, and electrocardiograms (ECGs). Inclusion Criteria for Participants with Alzheimer's Disease (AD): * Are between 55-85 years of age * Have gradual and progressive changes in memory function, as reported by the participant or their study partner, for greater than or equal to (≥) 6 months at screening, as well as a clinical diagnosis of mild cognitive impairment due to AD or mild-to-moderate AD dementia as determined by the investigator or based on medical history. * Have Mini-Mental State Exam (MMSE) score ≥16 * Have positive amyloid positron emission tomography (PET) * Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant. A second person may serve as backup. * For participants on symptomatic treatments for AD (for example, cholinesterase inhibitors, memantine) the dosing regimen must be stable, in the opinion of the investigator, for at least 8 weeks before randomization to a study intervention, and the dosing regimen is planned to remain stable. Exclusion Criteria for all Participants: * Have currently, or a history of, serious or unstable neurological or psychological disease (except for AD for participants in the AD cohorts). * Have currently, or a history of, significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological diseases. * Have currently, or a history of, allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone. * Have currently, or a history of, clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions. * Have currently, or a history of cancer within the past 5 years except for some early skin cancers that have been resected with no evidence of metastatic disease for 3 years. * Have received any amyloid-targeting therapy (ATT), whether marketed or investigational; or have received active immunization against amyloid beta (Aβ). * Have received an active study intervention, within the last 30 days, in a clinical study involving an IMP. * Are pregnant or breastfeeding or intend to become pregnant or to breastfeed during the study; * Have an abnormal blood pressure, pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension. Exclusion Criteria for Healthy Participants: * Have a locally read brain magnetic resonance imaging (MRI) that demonstrates any clinically significant findings, including but not limited to, findings suggestive of CAA, that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study. * Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), or have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP. * Have a family history of early onset AD (AD diagnosed before 65 years of age). Exclusion Criteria for Participants with AD: * Contraindications or unable to tolerate MRI * Have a centrally read brain MRI that demonstrates the presence of Amyloid-Related Imaging Abnormalities with Edema/Effusion (ARIA-E), greater than (\>)4 cerebral microhemorrhages, any evidence of superficial siderosis, any macrohemorrhage, or severe white matter disease; \>2 lacunar infarcts or any territorial infarct \>1 square centimeters (cm²); significant abnormalities that suggest another potential etiology for progressive dementia, or clinically significant finding that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study. * Contraindications to amyloid PET scan.
Study sites (13)
CA
- CenExel ACT · Anaheim, CA 92801 · Study contact · 714-774-7777Amina Haggag · Principal investigatorMore trials in Anaheim
- Irvine Clinical Research · Irvine, CA 92614 · Study contact · 949-753-1663Elly Lee · Principal investigatorMore trials in Irvine
- Collaborative Neuroscience Network - CNS · Los Alamitos, CA 90720 · Study contact · 714-799-7799Steven Reynolds · Principal investigatorMore trials in Los Alamitos
FL
- Fortrea Clinical Research Unit · Daytona Beach, FL 32117 · Study contact · 386-366-6400Chiamaka Iheme · Principal investigatorMore trials in Daytona Beach
- K2 Medical Research - The Villages · Lady Lake, FL 32159 · Study contact · 321-278-5590Craig Curtis · Principal investigatorMore trials in Lady Lake
- K2 Medical Research · Maitland, FL 32751 · Study contact · 407-232-9262Brandon Lenox · Principal investigatorMore trials in Maitland
- Charter Research · Orlando, FL 32803 · Study contact · 407-337-1000Diana Balsalobre · Principal investigatorMore trials in Orlando
- Progressive Medical Research · Port Orange, FL 32127 · Study contact · 386-304-7070Alexander White · Principal investigatorMore trials in Port Orange
- Alzheimer's Research and Treatment Center · Stuart, FL 34996 · Study contact · 772-675-0000Adam Falchook · Principal investigatorMore trials in Stuart
- K2 Medical Research - Tampa · Tampa, FL 33634 · Study contact · 813-800-5252Kelley Wilson · Principal investigatorMore trials in Tampa
- Charter Research · The Villages, FL 32162-2698 · Study contact · 352-775-1000Jeffrey Norton · Principal investigatorMore trials in The Villages
GA
- Accel Research Sites - NeuroStudies Clinical Research Unit · Decatur, GA 30030 · Study contact · 404-475-0552Marshall Nash · Principal investigatorMore trials in Decatur
MI
- QUEST Research Institute · Farmington Hills, MI 48334 · Study contact · 248-957-8940Aaron Ellenbogen · Principal investigatorMore trials in Farmington Hills