The amyloid-beta peptide has been evaluated across numerous clinical trials spanning Phase 1, Phase 2, and Phase 3 investigations. These studies primarily focus on neurodegenerative and cognitive disorders, including Alzheimer's disease, mild cognitive impairment, post-stroke dementia, vascular mild cognitive impairment, Parkinson's disease, and Down syndrome, as well as systemic conditions like transthyretin cardiac amyloidosis. Research initiatives sponsored by commercial organizations such as AstraZeneca and Avid Radiopharmaceuticals, alongside academic institutions like Massachusetts General Hospital and Chang Gung Memorial Hospital, demonstrate diverse recruitment statuses ranging from completed to active and recruiting. Prominent diagnostic investigations, such as NCT00692705 and NCT00857532, have utilized positron emission tomography imaging ligands to assess beta-amyloid protein deposition and cognitive dysfunction in patients.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05806697 | RECRUITING | Alzheimer Disease; Memory Complaint; Memory Disorders |
Institut National de la Santé Et de la Recherche Médicale, France |
2023-04-14 | |
| NCT06470061 | NOT_YET_RECRUITING | Alzheimer Disease; Mild Cognitive Impairment; Cognitive Decline |
Zaparackas and Knepper LTD |
2024-07 | PHASE2 |
| NCT06661564 | RECRUITING | Alzheimer Disease |
University Hospital, Tours |
2025-07-09 | |
| NCT05361382 | ACTIVE_NOT_RECRUITING | Alzheimer Disease |
Tharick Pascoal |
2022-03-02 | PHASE1 |
| NCT07343999 | NOT_YET_RECRUITING | Transthyretin Cardiac Amyloidosis |
Universidad de Burgos |
2026-06 | |
| NCT05642429 | ACTIVE_NOT_RECRUITING | Alzheimer Disease |
Institute for Molecular Medicine |
2023-02-27 | PHASE1 |
| NCT06194955 | COMPLETED | Incretin Effect |
University of Copenhagen |
2023-01-04 | |
| NCT06604390 | COMPLETED | Elderly Individuals Aged 60 Years or Older; Mild Cognitive Impairment (MCI) |
Rahmi Novita Yusuf |
2024-02-01 | |
| NCT05164536 | COMPLETED | Alzheimer Disease |
Invicro |
2021-08-27 | PHASE1 |
| NCT03902548 | COMPLETED | Alzheimer Disease |
Five Eleven Pharma, Inc. |
2018-02-21 | PHASE1 |
| NCT03290326 | COMPLETED | Alzheimer Disease |
Massachusetts General Hospital |
2017-11-27 | |
| NCT02395978 | COMPLETED | Major Depressive Disorder |
BioLite, Inc. |
2015-04-10 | PHASE2 |
| NCT04792762 | COMPLETED | Glucose Metabolism Disorders |
University Hospital, Gentofte, Copenhagen |
2018-06-12 | |
| NCT02747472 | COMPLETED | Glucose Metabolism |
University Hospital, Gentofte, Copenhagen |
2016-04 | |
| NCT04588649 | COMPLETED | Post-stroke Dementia; Vascular Mild Cognitive Impairment |
Chang Gung Memorial Hospital |
2016-01-04 | PHASE2 |
| NCT01127633 | TERMINATED | Alzheimer's Disease |
Eli Lilly and Company |
2010-12 | PHASE3 |
| NCT00671060 | COMPLETED | Intrauterine Fetal Demise |
Gynuity Health Projects |
2008-10 | PHASE3 |
| NCT00857532 | COMPLETED | Parkinson's Disease |
Avid Radiopharmaceuticals |
2009-01 | PHASE2 |
| NCT01020838 | COMPLETED | Alzheimer Disease |
Lantheus Biosciences Ltd. |
2009-11 | PHASE3 |
| NCT00928304 | COMPLETED | Down Syndrome; Amyloid Beta-protein |
Lantheus Biosciences Ltd. |
2009-06 | PHASE2 |
| NCT00750282 | COMPLETED | Alzheimer Disease; Amyloid Beta-Protein |
Lantheus Biosciences Ltd. |
2008-08 | PHASE2 |
| NCT00692705 | COMPLETED | Alzheimer´s Disease |
AstraZeneca |
2008-01 | PHASE1 |
| NCT00968097 | TERMINATED | Alzheimer's Disease |
Institute for Neurodegenerative Disorders |
2008-04 | PHASE1 |
| NCT00556660 | COMPLETED | Alzheimer Disease |
Institute for Neurodegenerative Disorders |
2007-09 | PHASE1 |
| NCT00287248 | COMPLETED | Alzheimer Disease |
Institute for Neurodegenerative Disorders |
2006-02 | PHASE1 |
| NCT00320658 | COMPLETED | Malaria |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-03 | PHASE1 |
| NCT00340431 | COMPLETED | Plasmodium Falciparum Malaria; Vaccines |
National Institute of Allergy and Infectious Diseases (NIAID) |
2004-06-09 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-07-07)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- β-Amyloid (1-42), human Solubility in DMSO
- β-Amyloid (1-42), human Stock Solution
- β-Amyloid (1-42), human Storage
- β-Amyloid (1-42), human Stability
- β-Amyloid (1-42), human Molecular Weight
- β-Amyloid (1-42), human CAS Number
- β-Amyloid (1-42), human Chemical Structure (2D and 3D)
- β-Amyloid (1-42), human SDS｜MSDS