Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical T… (NCT06489015) | Clinical Trial Compass
CompletedEarly Phase 1
Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials
China30 participantsStarted 2024-08-27
Plain-language summary
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD).
Who can participate
Age range
50 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 50 and 85 years (inclusive), with no gender restrictions;
. Meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia";
. The severity of the disease was mild or moderate, that is, 1 ≤ Clinical dementia scale total score (CDR-GS) score ≤ 2;
. Hachinski Ischemia Scale (HIS) ≤ 4;
. Geriatric Depression Scale (GDS) score between 0 and 20 (inclusive);
. Memory impairment present for at least 12 months with evidence of progression;
. Previous PET CT/MRI scan can be provided to confirm the diagnosis of AD at the time of screening. We may provide qualified head MRI films or head MRI plain scan and oblique coronal hippocampal scan within 12 months: The likelihood of Alzheimer's disease on MRI was highest when there were fewer than or equal to two infarcts larger than 2 cm in diameter and no infarcts in key areas such as the thalamus, hippocampus, entorhinal cortex, parorhinal cortex, angular gyrus, cortex, or other subcortical gray matter nuclei (Medial Temporal Atrophy Visual Rating Scale \[MTA\] grade of 2 or greater);
. Female participants must be postmenopausal for at least 24 weeks, have undergone sterilization surgery, or if of childbearing potential, along with fertile males, agree to use effective contraception during the study. Women of childbearing potential or those postmenopausal for less than 24 weeks require a negative pregnancy test at screening;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial used recombinant human serum albumin — which is a lab-made version of a protein normally found in blood — can you explain what the thinking is behind using it for Alzheimer's, and whether the early Phase 1 results showed any concerning safety signals I should know about?
2This was an early Phase 1 trial, which typically focuses on safety rather than proving the treatment works — so how much weight should we give to the ADAS-Cog cognitive scores they measured, and does this data change any of your recommendations for my situation?
3The trial has already completed recruitment and data collection, so are there published results available yet, and if so, what do they actually show about adverse events and cognitive outcomes?
4Given that this was an exploratory Phase 1 study with a relatively small number of participants, are there larger or more advanced trials of recombinant human serum albumin for Alzheimer's that might now be open to enrollment and worth considering?
5Before looking at experimental approaches like this one, are there standard Alzheimer's treatments or other currently enrolling trials you think I should consider first, given where I am in my diagnosis?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Investigators believe that the main causes of cognitive impairment are frontotemporal dementia, dementia with Lewy bodies, vascular dementia, dementia caused by Parkinson's disease, dementia caused by epilepsy, dementia caused by craniocerebral injury, and dementia related to central nervous system infection and immunity;
. Known history of allergy or allergic reactions to yeast or yeast-derived products, any component of the study formulation, individuals with an allergic constitution (multiple drug or food allergies), a history of severe systemic allergic reactions to biologics, or those deemed unsuitable for trial drug treatment by the investigator;
. Active or historical cardiovascular disorders at screening or conditions deemed inappropriate for human albumin treatment by the investigator, specifically including but not limited to: hypertension (systolic blood pressure \>160 mmHg or diastolic \>100 mmHg, unless well-controlled with medication and stable in the investigator's judgment), severe anemia, acute cardiac events, significant heart or pulmonary structural diseases, severe arrhythmias, decompensated heart failure (in normal or high volume states), unstable angina, myocardial infarction within 6 months prior to screening, medically treated tachycardia/bradycardia, third-degree atrioventricular block, etc.;
. Active metabolic disorders or history thereof at screening, or concurrent renal impairment deemed unsuitable for serum albumin therapy by the investigator, such as diabetic kidney disease, hyperuricemia-related renal injury, sleep apnea-associated renal damage, hyperlipidemia-induced renal impairment, etc.;
. Presence of severe underlying diseases at screening that the investigator deems inappropriate for study participation, including but not limited to active malignancy, pulmonary edema, bleeding tendencies or active bleeding disorders, uncontrolled infections (including spontaneous bacterial peritonitis), thyroid dysfunction (Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\], version 5.0), etc.;
. Positive for hepatitis B surface antigen (HBsAg), positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), positive for hepatitis C antibody (HCV Ab) with detectable hepatitis C ribonucleic acid (HCV-RNA), positive for human immunodeficiency virus antibody (HIV Ab), or positive for Treponema pallidum (syphilis) antibodies at screening;
. Presence of the following laboratory abnormalities at screening:
. Patients had or had a history of a neurological disease at the time of screening, such as a neurological disease with unstable control;