Phase 1 Parkinson's Disease Trial, Not Yet Recruiting NCT05094011 Sponsor: Taiwan Mitochondrion Applied Technology Co., Ltd. Condition: Parkinson's Disease
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Phase 1 Parkinson's Disease Trial, Not Yet Recruiting

NCT05094011
Not Yet Recruiting Phase 1

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have signed and dated a consent form agreeing to take part in the trial
  • People who are between 45 and 70 years old (inclusive) at the screening stage
  • People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's that arises on its own, without a known cause) according to a recognised set of medical diagnostic guidelines
  • People who were diagnosed with Parkinson's disease at least 5 years ago
  • People whose Parkinson's symptoms improve noticeably when they take levodopa or a dopamine agonist medication, specifically showing at least a 33% improvement on a standard motor assessment scale between their "off" and "on" medication states
  • People whose Parkinson's disease is rated as Stage 3 or 4 on the modified Hoehn & Yahr scale during their "on" medication time (meaning moderate to relatively advanced movement difficulties)
  • People whose Parkinson's medications have remained unchanged for at least 2 months before the screening visit
  • People whose brain MRI scan does not show significant shrinkage of the brain or any brain condition other than Parkinson's disease
  • People who score 24 or higher on the Mini-Mental State Examination, a standard test of thinking and memory ability
  • People who score below 29 on the Beck Depression Inventory (BDI-II) and below 25 on the Hamilton Rating Scale for Depression (HAM-D-17), which are standard tools used to measure depression levels

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have an atypical form of Parkinsonism or Parkinsonism caused by another condition (secondary Parkinsonism)
  • People who have a brain or nervous system degenerative condition other than Parkinson's disease
  • People who are unable to undergo MRI or PET scanning
  • People who have a condition that would make it unsafe to undergo blood clotting procedures, general anaesthesia, or a type of brain surgery that uses precise 3D targeting (stereotactic neurosurgery)
  • People who have taken part in another clinical trial and received an experimental treatment within 4 weeks before screening
  • People who have had brain surgery or had a device implanted for Parkinson's disease within the 2 years before screening
  • People who have had a major surgery within the 6 months before screening
  • People who have significant heart disease, including: heart failure classified as NYHA Class III or IV (moderate to severe symptoms); uncontrolled high blood pressure (above 140/90 mmHg); or a history of serious irregular heart rhythms involving the lower chambers of the heart
  • People who have had a cancer diagnosis within the 2 years before screening
  • People who have been diagnosed with an autoimmune disease or have a weakened immune system and need ongoing treatment with steroids or immune-suppressing medications
  • People who have another serious health condition, including a history of schizophrenia or other psychotic disorders, stroke, seizure, traumatic brain injury, or infection of the brain or spinal cord, where the trial doctor believes participation could be harmful
  • People who have a psychiatric condition, addiction, or any other condition that affects their ability to give fully informed consent or to complete all required trial assessments
  • People who test positive for any of the following infections during screening: HIV (antigen/antibody combo test or nucleic acid test), Hepatitis C (anti-HCV test or nucleic acid test), Hepatitis B (surface antigen test or nucleic acid test), or syphilis (rapid plasma reagin test)
  • People whose blood test results show any of the following: haemoglobin below 9.0 g/dL; a type of white blood cell count (ANC) below 1,500/μL; or platelet count below 100,000/μL
  • People whose blood chemistry results show any of the following abnormalities: total bilirubin more than 1.5 times the upper limit of normal; liver enzymes AST or ALT more than 2.5 times the upper limit of normal; liver enzyme r-GT more than 2.5 times the upper limit of normal; liver enzyme ALP more than 2.5 times the upper limit of normal; blood albumin (a protein) below 3.0 g/dL; or creatinine (a kidney marker) more than 1.5 times the upper limit of normal
  • People who are currently breastfeeding or who have a positive pregnancy test at the screening visit
  • People who are capable of becoming pregnant, or whose male partner is in a relationship with someone capable of becoming pregnant, and who are unwilling to use at least two forms of contraception (including at least one barrier method) from screening through to the end of the trial; accepted methods include hormonal contraception (oral, injected, or implanted), an intrauterine device or system, or barrier methods such as condoms or a diaphragm/cervical cap
  • People who have any other condition that, in the trial doctor's judgement, could make participation harmful to them

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 July 2026

Contact this trial

Principal Investigator: Chi-Tang Tu, Ph. D., Taiwan Mitochondrion Applied Technology Co., Ltd.

Phone: 886-03-5820208

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Taiwan Mitochondrion Applied Technology Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 March 2026
Est. completion
30 September 2027

Primary endpoints

Grading of Adverse Events; Routine physical examinations; Changes in physical examinations: clinical standard neurological examination [Safety of Mitocell]; Changes in vital signs: blood pressure [Safety of Mitocell]; Changes in vital signs: pulse rate [Safety of Mitocell]; Changes in vital signs: body temperature [Safety of Mitocell]; Changes in clinical laboratory safety screen: haematology - hemoglobin [Safety of Mitocell]; Changes in clinical laboratory safety screen: Platelet count [Safety of Mitocell]; Changes in clinical laboratory safety screen: white blood cell (WBC) counts [Safety of...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov