Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical T… (NCT06489015) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials
China30 participantsStarted 2024-06-28
Plain-language summary
This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin (rHSA, hereafter referred to as the "investigational drug") in patients with mild to moderate Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 ratio to receive the investigational drug at doses of 20g, 30g, or 40g, for assessments of safety and preliminary efficacy. Stratification factors will be based on the severity classification (mild; moderate) as indicated by the total score on the Clinical Dementia Rating Scale - Global Score (CDR-GS) during the screening period.
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";
. Mild to moderate disease stage, as indicated by a Clinical Dementia Rating Scale - Global Score (CDR-GS) ≤ 2;
. Hachinski Ischemia Scale (HIS) ≤ 4;
. Geriatric Depression Scale (GDS) score between 0 and 10 (inclusive);
. Memory impairment present for at least 12 months with evidence of progression;
. Availability of a qualified brain MRI scan within 1 month prior to enrollment, or willingness to undergo an MRI scan, showing: No more than 2 infarcts larger than 2 cm, no infarcts in key areas such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, cortical or subcortical gray matter nuclei, and imaging features highly suggestive of Alzheimer's Disease (Medial Temporal Lobe Atrophy \[MTA\] scale rating ≥ 2);
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
The change in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) score from baseline to Week 25 post-treatment.
Timeframe: from baseline to Week 25 post-treatment
. 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
. Dementia secondary to other causes: frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson's disease dementia, dementia due to epilepsy, post-traumatic dementia, central nervous system infections, and immune-mediated dementias, among others;
. 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:
. History or presence of neurological disorders at screening, such as stroke, neuromyelitis optica, Parkinson's disease, epilepsy, etc.;