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Clinical efficacy and safety of Human Albumin in the treatment of mild to moderate Alzheimer's disease

Clinical efficacy and safety of Human Albumin in the treatment of mild to moderate Alzheimer's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011539
Enrollment
Unknown
Registered
2017-06-01
Start date
2017-07-01
Completion date
Unknown
Last updated
2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's disease

Interventions

Albumin infusion group:Albumin10g (20%, 50ml) infusion1/per 2weeks

Sponsors

Guangzhou Huiai Hosptial (The Affiliated Brain Hospital of Guangzhou Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. aged 50 to 90 years; 2. Male/Female; 3. MMSE score more than 10 points and 24 points less than; 4. Possible AD is diagnosis according to the NINCDS-ADRDA standard; 5. There have been imaging scans of the head (CT or MRI) to support the diagnosis of AD, and these imagings were performed within the past six months or before admission; 6. if not otherwise specified, patients with underlying disease before the baseline must remain clinically stable; 7. Clinical laboratory result must be within the normal range, or if abnormal, no clinical significance must be confirmed by clinical investigator; 8. It is allowed to combine with other medication, but not the forbid medication describe in research plan, and if not otherwise specified, the subjects had to accept a stable dose of combined medication for at least 1 months or 5 half-life of drugs (prevail for a longer term) before baseline; 9. Informed consent shall be signed by the patient himself or his legal guardian prior to the screening. 10. subjects must have relatives / caregivers.

Exclusion criteria

Exclusion criteria: 1. History of past illness including those may affect cognitive function, but can be differentiated from AD diseases, such as schizophrenia, depression and Parkinson's disease, multi infarct dementia, cerebral vascular disease caused dementia, Huntington's disease, Pick disease, cortex - striatum - spinal cord degeneration (CJD), Lewy body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, epilepsy, subdural hematoma or multiple sclerosis, and the following illness or in any of the following conditions: the subjects suffered from human immunodeficiency virus disease, neurosyphilis, or structural abnormalities in the brain known or persistent neurological defects the head after severe trauma; 2. Suffer from active or uncontrolled epilepsy, asthma, central nervous system infections, other neurodegenerative diseases, and other advanced severe progressive instability diseases; 3. Subjects suffered from dementia and were accompanied by other organic diseases, or AD accompanied by delirium (according to the DSM-IV standard); 4. Serious disability can not meet the needs of clinical research (such as blindness, severe deafness, communication, serious language disorders, not communication); 5. Improved Hachinski ischemia index scale (MHIS) score > 4; 6. Allergic to white protein preparations; 7. Less than 40 kg in weight; 8. Pregnant or lactating women (pregnant defined as the period including pregnant to the termination of pregnancy, laboratory tests show positive urine HCG); 9. Women of reproductive age plan pregnant during the study period; 10. Patients with abnormal liver function. Elevated transaminase is considered clinically significant; 11. Patients with severe renal impairment; 12. Severe biliary obstruction.

Design outcomes

Primary

MeasureTime frame
ADAS-Cog;

Secondary

MeasureTime frame
MMSE;ADCS-ADL;NPI;CDR-SB;

Countries

China

Contacts

Public ContactYuping Ning

Guangzhou Huiai Hosptial (The Affiliated Brain Hospital of Guangzhou Medical University)

ningjeny@126.com+86 18922165368

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 17, 2026