AzTrials
AzTrials

Alzheimer DiseasePhase 2NCT04482413

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

A Phase 2 study testing AstroStem in people with Alzheimer Disease, run by Nature Cell Co. Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
AstroStem
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
No sites listed yet
Study dates
1 Feb 2023to 20 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Patients who show signs of Acquired Immunodeficiency Syndrome (AIDS), Hepatitis B Virus (HBV), Hepatitis C (HCV), Venereal Disease Research Laboratory (VDRL)
  • Patients who have any conditions that would contraindicate an MRI, such as the presence metallic objects in the eyes, skin, or heart
  • Patients 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
  • Patients 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)
  • Patients who have suspected active lung disease based on chest X-ray
  • Patients who are hypersensitive to fetal bovine serum or penicillin
  • Patients who are currently using immunosuppressants, cytotoxic drug, corticosteroids or similar steroidal anti-inflammatory medication (e.g., Prednisone) on a regular basis (exceptions allowed include; regular use of steroidal nasal sprays, topical steroids, and estrogen-replacement therapy)
  • Patients for whom the investigator judges the liposuction may cause a problem

Trial locations and contacts

No sites are listed yet.

Hugh Lee contact

301-540-2600

hughlee@kcrnresearch.com

About this study

Official title: 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

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.

Being tested
AstroStem, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AstroStemDrug

    Treatment group receive AstroStem(Autologous adipose tissue derived mesenchymal stem cells, AdMSCs) every 4 weeks from Week 0 to Week 36.

  • PlaceboDrug

    Also called AstroStem Placebo

    Placebo control group receive 20 mL of Saline and auto serum every 4 weeks from Week 0 to Week 36.

Study groups in NCT04482413
Study groupRoleWhat they receive
TreatmentExperimentalTreatment group will be administered via intravenously AstroStem which consists of two syringes and each syringe contains 2.0 x 10^8 cells / 20 mL of saline with 30% auto-serum.
Receives: Drug: AstroStem
Placebo ControlPlacebo comparatorPlacebo control group will receive AstroStem Placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SUVR (Standard Uptake Value Ratio)

    Standard Uptake Value Ratio (SUVR) of the Amyloid PET scan

    Measured: Baseline and 52 Weeks

Secondary outcomes (7)

  1. CDR-SB score (Clinical Dementia Rating Sum of Boxes)

    Changes of CDR-SOB from baseline at Week 52 Score range: 0-18.0 0 = normal, 0.5-4.0 = questionable cognitive dementia, 4.5-9.0 = mild dementia, 9.5-15.5 = moderate dementia, and 16.0-18.0 = severe dementia

    Measured: Baseline and 52 Weeks

  2. ADAS-Cog-11 score (Alzheimer's Disease assessment Scale-Cognitive Subscale (11 items))

    Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from Baseline at Week 52 Score range: 0-70 A score of 70 represents the most severe impairment and 0 represents the least impairment

    Measured: Baseline and 52 Weeks

  3. MMSE (Mini-mental status examination)

    Change from baseline to Week 52 in the Mini-mental status examination (MMSE) score. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.

    Measured: Baseline and 52 Weeks

  4. ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory)

    Change from baseline to Week 52 in the ADCS-ADl MCI 0-53 A score of 0 represents the most severe impairment and 53 represents the least impairment

    Measured: Baseline and 52 Weeks

  5. C-SSRS (Columbia Suicide Severity Rating Scale)

    Change from baseline to Week 52 in the Columbia Suicide Severity Rating Scale (C-SSRS) score. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.

    Measured: Baseline and 52 Weeks

  6. NPI (Neuropsychiatric Inventory)

    Change from baseline to Week 52 in the Neuropsychiatric Inventory (NPI) score. The NPI is a structured interview with a caregiver or qualified study partner (defined as having direct contact > 2 days/week) that evaluates both presence and severity of 12 neuropsychiatric features which include: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability, lability, apathy, aberrant motor behavior, night-time behavior, and appetite/ eating changes. If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale ranging from 1 to 3 (mild to severe).

    Measured: Baseline and 52 Weeks

  7. 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

    Measured: Baseline and 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion30 May 2024 (estimated)
  4. Study completion20 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482413
Sponsor's protocol ID
AST-ADP2-US02
Status last verified
Apr 2022
First submitted
17 Jul 2020
Last updated
28 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AstroStem in people with Alzheimer Disease, run by Nature Cell Co. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hugh Lee (301-540-2600, hughlee@kcrnresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SUVR (Standard Uptake Value Ratio) (time frame: Baseline and 52 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04482413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in