Printed from Voxsanity (voxsanity.com.au) — NCT06432166 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Alzheimer's Disease Trial, Not Yet Recruiting
NCT06432166
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 aged 55 to 85 years old (inclusive) at the time of signing the consent form.
- People who have noticed memory concerns themselves, or whose family member, carer, or doctor has noticed memory concerns on their behalf.
- People who score between 24 and 30 (inclusive) on a standard memory and thinking test called the Mini-Mental State Exam (MMSE), for those being assessed for early memory impairment linked to Alzheimer's disease.
- People who score 0.5 on a standard assessment called the Clinical Dementia Rating (CDR), with a Memory Box score of at least 0.5, for those being assessed for early memory impairment linked to Alzheimer's disease.
- People who meet recognised medical criteria for mild Alzheimer's-type dementia, based on guidelines published in 2018 by the National Institute on Aging and Alzheimer's Association.
- People who score 0.5 on the CDR overall and also score 0.5 or higher in at least one area of daily living (personal care, home and hobbies, or community activities), or who score 1.0 on the CDR overall, for those being assessed for mild Alzheimer's disease.
- People who score 20 or above on the MMSE, for those being assessed for mild Alzheimer's disease.
- People whose memory test results fall within a specific low range on a word recall test (called the Logical Memory II subscale), adjusted for their level of education: a score of 11 or less for those with 16 or more years of education, 9 or less for those with 8 to 15 years of education, or 6 or less for those with 0 to 7 years of education.
- People who test positive for amyloid in the brain, confirmed through a specific blood test called the C2N Precivity2 Plasma test, which measures certain proteins in the blood to estimate the likelihood of amyloid build-up in the brain.
- People who have been on stable doses of any permitted medications for at least 4 weeks before screening, including memory medications such as memantine or cholinesterase inhibitors if those have been stable for at least 12 weeks before screening.
- People who score 14 or less on a standard depression screening tool called the Geriatric Depression Scale.
- People who have a study partner (such as a family member or carer) who has regular contact with them (around 10 hours per week or more on average) and is able to attend most study visits with them.
- People who have sufficient vision and hearing to be able to complete thinking and memory tests.
- People who are in generally good health, without other conditions expected to interfere with the study.
- Women who are not pregnant, not breastfeeding, and are not able to become pregnant — meaning they are at least two years past menopause or have had a surgical procedure that prevents pregnancy.
- People who have completed at least six years of schooling, or who have a consistent work history.
- People who speak English fluently.
- People who are able to give written informed consent and have the mental capacity to do so.
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 another significant brain or nervous system condition, such as Parkinson's disease, Huntington's disease, multiple sclerosis, a history of seizures, brain tumour, normal pressure hydrocephalus, multiple small strokes (multi-infarct dementia), progressive supranuclear palsy, a blood clot under the skull (subdural hematoma), or a history of serious head injury with lasting effects, or known abnormal brain structure.
- People who have had a major depressive episode or bipolar disorder in the past year, or who have had psychotic symptoms, agitation, or significant behavioural problems in the past 3 months, if these could make it difficult to follow the study procedures.
- People who have a history of schizophrenia (as defined by standard diagnostic criteria).
- People who have had a problem with alcohol or drug misuse or dependence in the past 2 years (as defined by standard diagnostic criteria).
- People with a significant or unstable medical condition — such as uncontrolled high blood pressure, uncontrolled diabetes, or serious heart, lung, kidney, liver, hormonal, or other health problems — that the study doctor believes could put them at risk or affect study results.
- People who have been diagnosed with a primary or returning cancer in the past 5 years, with the exception of certain low-risk skin cancers or early-stage cancers that have been fully treated (such as basal cell carcinoma, cervical carcinoma in situ, or prostate cancer in situ with normal test results after treatment).
- People with significantly abnormal levels of vitamin B12 or thyroid function that could interfere with the study — a low B12 result is disqualifying unless follow-up blood tests show it is not causing any physical effects.
- People with significantly abnormal results on screening blood tests or on a heart tracing test (ECG).
- People who are currently living in a skilled nursing facility.
- People who are taking any medications that are not permitted by the study, including drugs that block a chemical in the brain called acetylcholine (centrally acting anticholinergic drugs).
- People who have taken any experimental (investigational) drug within 4 weeks or 5 half-lives of that drug before screening, whichever period is longer.
- People who have a current blood clotting or bleeding disorder, or who have significantly abnormal blood clotting test results (PT or PTT) at screening.
- People who cannot have an MRI scan — for example, due to claustrophobia, metal or magnetic implants in the body, or a cardiac pacemaker.
- People whom the study doctor at the trial site considers ineligible for any other reason.
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.
Contact this trial
Principal Investigator: Paul Newhouse, M.D., Vanderbilt University Medical Center
Phone: 515-296-9916
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 2
Sponsor
MTI Biotech Inc
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
30 June 2028
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Safety/Tolerability (adverse events); Change in dicarbonyl protein adducts
Can't join this trial?
Data last synced from ClinicalTrials.gov: 5 August 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.