Clinical Trials

Numerous clinical trials evaluate beta-amyloid protein dynamics and targeted diagnostic or therapeutic approaches for Alzheimer's disease, including mild cognitive impairment, as well as post-stroke dementia, vascular cognitive impairment, and Parkinson's disease. Ranging from Phase 1 through Phase 3 trials to exploratory PET imaging investigations quantifying in vivo amyloid plaque burden, these studies encompass completed, active recruiting, and non-recruiting protocols. Sponsorship is provided by academic medical centers, university hospitals, and commercial pharmaceutical organizations such as AstraZeneca and Avid Radiopharmaceuticals.

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
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
NCT06604390 COMPLETED
Elderly Individuals Aged 60 Years or Older; Mild Cognitive Impairment (MCI)
Rahmi Novita Yusuf
 2024-02-01
NCT05282641 COMPLETED
Glucose Metabolism; Lipid Metabolism
Maastricht University Medical Center
 2021-05-26
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
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
NCT01197963 TERMINATED
Type 2 Diabetes Mellitus
The University of Texas Health Science Center, Houston
 2010-09
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

(data from https://clinicaltrials.gov, updated on 2026-07-07)

Check the β-Amyloid (25-35) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a toxic peptide fragment, β-amyloid (25-35) spontaneously self-assembles into fibrillar aggregates that interact with neuronal membrane lipid bilayers, disrupting cellular calcium homeostasis and inducing oxidative stress along with inflammatory signaling cascades. This biochemical disruption leads to severe synaptic loss, mitochondrial dysfunction, and progressive neuronal cell death, which directly drives the neurodegenerative pathology and memory impairment observed in clinical trial conditions such as Alzheimer's disease.

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>).

Jump to

Note: Technical data last updated: Sep 1, 2026.