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Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients With Alzheimer's Disease

NCT04482413•Nature Cell Co. Ltd.

View on ClinicalTrials.gov

Summary

This is a phase 2b randomized, double-blind, Placebo-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem vs. Placebo treatment in patients with mild Alzheimer's Disease(AD). Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem every 4 weeks from Week 0 to Week 36. On the other hand, patients who are randomized into the placebo control group will receive Placebo every 4 weeks from Week 0 to Week 36. After the final administration, patients will be scheduled for two follow-up visits, at Weeks 44 and 52, to assess efficacy and safety endpoints.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patients aged 50 and above at the time of signing the Informed Consent Form
•Patients who can understand and provide written informed consent (assent)
•Patients who have a diagnosis of probable mild Alzheimer's Disease(AD) according to the National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria within one year of the start of treatment
•Patients who have an MMSE Score of 20 to 24 at screening
•Patients who have a Clinical Dementia Rating (CDR)-Global Score of 0.5 to 1 at baseline
•Patients who have any FDA-approved AD medication (donepezil, galantamine, memantine, rivastigmine or any combination) since their AD diagnosis receiving a stable dose of medical teratment for at least 12 weeks prior to Screening and were to stay on a stable dose during the study
•Patients who have one (or more) identified adult caregiver (study partner) who is able to read, understand, and speak the designated language at the study site; who either lives with the subject or sees the subject for ≥2 hours/day ≥4 days/week; and who agrees to accompany the subject to each study visit and to participate in the subject's clinical assessments
•Patients who have a diagnosis of probable mild AD according to Amyloid PET scan at screening

Exclusion Criteria

•Female patients who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
•Patients who have signs of delirium
•Patients who have had a cortical stroke within the preceding 2 years
•Patients who have a prolonged QTc interval at screening; \>450 msec for males or \>470 msec for females
•Patients who have a diagnosis of severe white matter hyperintensity (WMH), which is defined as ≥25mm of the deep white matter and ≥10mm of the periventricular capping/banding in lengths
•Patients who have a diagnosis of dementia or cause of cognitive impairment other than AD
•Patients who have a significant abnormal result in laboratory tests, in the opinion of the investigator
•Patients who have participated in any investigational drug, stem cell therapy, or device trial within the previous 3 months at screening
•Patients with any current psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the subject´s ability to complete the study
•Patients who are known to have autosomal dominant mutation-associated presenile AD
+8 more criteria

Key Dates

Start Date

February 1, 2023

Primary Completion Date

May 30, 2024

Completion Date

December 20, 2024

Last Updated

September 28, 2022

Enrollment

100

ESTIMATED participants

Conditions

Alzheimer Disease

Interventions

AstroStem

DRUG

Placebo

DRUG

Contacts

Hugh Lee

CONTACT

301-540-2600 hughlee@kcrnresearch.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

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