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

NCT03117738 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AST-ADP2-US01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group comparison study in subjects with Alzheimer's Disease. Following first screening period, subjects will be randomly assigned into one of the following arms: AstroStem and placebo control in a 1:1 ratio. AstroStem or placebo control will be administered via I.V. at Week 0. This procedure will be repeated 9 times at 2-week interval. Subjects will be scheduled for two follow-up visits at Weeks 30 and 52 to evaluate primary and secondary outcome endpoints.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Treatment Related Adverse Events

  Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results

  30 Weeks

• ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive Subscale)

  Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 30 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment

  Baseline and 30 Weeks

Secondary Outcomes (6)

• MMSE (Mini-mental Status Examination)

  Baseline and 30 Weeks

• CDR-SOB (Clinical Dementia Rating-Sum of Boxes)

  Baseline and 30 Weeks

• NPI (Neuropsychiatric Inventory)

  Baseline and 30 Weeks

• GDS (Geriatric Depression Scale)

  Baseline and 30 Weeks

• ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living)

  Baseline and 30 Weeks

Study Arms (2)

AstroStem

EXPERIMENTAL

Drug: AstroStem

Placebo-Control

PLACEBO COMPARATOR

Other: Placebo-Control

Interventions

AstroStem DRUG

Autologous adipose tissue derived mesenchymal stem cells (AdMSC)

AstroStem

Placebo-Control OTHER

Saline with 30% auto-serum

Placebo-Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 50 and above at the time of signing the Informed Consent form
• Subjects who can understand and provide written informed consent (assent)
• Subjects who have diagnosis of probable mild-to-moderate Alzheimer disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria
• Subjects who have MMSE Score of 16 to 26 at screening
• Subjects who are taking FDA-approved AD medications (donepezil, galantamine, memantine, rivastigmine or their combinations) treatment on a stable dosage for at least 3 months prior to screening.
• Subjects who have one (or more) identified adult caregiver who is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥4 days/week; and agrees to accompany the subject to each study visit
• Subjects who have a designated study partner who will accompany the subject to all clinic visits and participate in the subject's clinical assessments

You may not qualify if:

• Subjects who are females who are pregnant, nursing, or of childbearing potential while not practicing effective contraception
• Subjects who have signs of delirium
• Subjects who have had cortical stroke within the preceding 2 years
• Subjects who have a prolonged QTc interval; \>450 msec in male or \>470 msec in female at screening
• Subjects who have 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
• Subjects who have diagnosis of dementia or cause of cognitive impairment other than Alzheimer's disease
• Subjects who have a significant abnormal result in laboratory tests, in the opinion of the investigator
• Subjects who have participated in any investigational drug, stem cell therapy, or device trial within the previous 3 months at screening
• Subjects 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
• Subjects who are known to have autosomal dominant mutation-associated presenile AD
• Subjects who show signs of AIDS (Acquired Immunodeficiency Syndrome), HBV (Hepatitis B Virus), HCV (Hepatitis C), VDRL (Venereal Disease Research Laboratory)
• Subjects who have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart
• Subjects who have \> 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite"), a single area of superficial siderosis, or evidence of a prior microhemorrhage as assessed by MRI
• Subjects who have history of malignant cancer within the last 5 years (The following is a partial list of conditions that are permissible for study entry: non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer)
• Subjects who have suspected active lung disease based on chest X-ray

Sponsors & Collaborators

• Nature Cell Co. Ltd.: lead

Study Sites (3)

ATP Clinical Research

Costa Mesa, California, 92626, United States

Location

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

Valden Medical

Honolulu, Hawaii, 96817, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Project Manager
• Organization: Nature Cell co., ltd

tin50@stemcellbio.com

02-545-4137

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: May 9, 2017
• Primary Completion: June 26, 2019
• Study Completion: August 31, 2019
• Last Updated: August 10, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-06

Locations

US (3)