Printed from Voxsanity (voxsanity.com.au) — NCT07066826 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Alzheimers Disease
Phase 3 Alzheimer's Disease Trial, Recruiting
NCT07066826
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
- The person (or their legal representative) is willing to take part and agrees to sign a consent form; if the person cannot sign due to memory or thinking difficulties, their legal representative may sign on their behalf.
- People aged 50 to 85 years, male or female.
- People who have been diagnosed with probable Alzheimer's disease based on recognised medical guidelines (NIA-AA 2011).
- People who have had worsening memory problems for at least 12 months that have gradually gotten worse over time.
- People who have had at least 5 years of formal schooling and are able to complete the thinking and memory tests required by the study.
- People whose Alzheimer's disease has been rated as mild to moderate (Stage 4 or 5 on the 2024 Revised Clinical Staging system, which corresponds to a CDR global score of 1 or 2).
- People whose score on a standard memory and thinking test (MMSE) falls between 11 and 26 out of 30.
- People who have had a brain scan (MRI) showing a certain level of shrinkage in a memory-related area of the brain; if a suitable MRI was done at a recognised hospital within the past 6 months and meets study requirements, a new scan may not be needed.
- People who are able to undergo a type of brain imaging scan called a PET scan.
- People whose score on a scale measuring stroke-related thinking problems (Hachinski Ischemic Score) is 4 or below.
- People whose score on a standard depression rating scale (HAMD-17) is 10 or below.
- People who do not show clear signs of localised brain or nerve damage on physical examination, apart from any damage caused by an injury outside the brain.
- People who have a reliable caregiver who spends time with them at least 4 days per week and at least 2 hours per day, is able to attend study visits with them, and can provide accurate information about how the person is doing throughout the study.
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 a known allergy to the active ingredient or other components of huperzine A controlled-release tablets or donepezil, or who cannot tolerate lactose.
- People whose memory or thinking problems are caused by something other than Alzheimer's disease, including: other brain-related conditions (such as Lewy body dementia, frontotemporal dementia, Huntington's disease, or Parkinson's disease); non-degenerative neurological conditions (such as vascular dementia, fluid on the brain, brain infections, oxygen deprivation, or brain injury); general health conditions affecting the brain (such as thyroid problems, liver failure, dialysis-related brain problems, syphilis of the brain, or HIV); or thinking problems caused by vitamin deficiencies (such as low folate or vitamin B12).
- People who have been diagnosed in the past 12 months with an unstable psychiatric condition that could interfere with study assessments, such as schizophrenia, bipolar disorder, major depression, delirium, or alcohol or substance dependence (as defined by the DSM-5 standard criteria).
- People whose brain MRI shows significant areas of damage, including large strokes, strokes in important memory-related brain areas, more than two strokes larger than 2 cm that may affect thinking, multiple small strokes affecting thinking, severe damage to the brain's white matter, brain bleeding likely to affect thinking, or fluid build-up in the brain; if a suitable MRI was done within 6 months before screening and meets study requirements, a new scan may not be needed.
- People who have seizures that are not well controlled, or whose thinking problems may be caused or worsened by repeated seizures or medications used to treat seizures.
- People who had a serious heart or stroke-related event within the 3 months before entering the study, such as unstable chest pain, a serious irregular heartbeat, a heart attack, severe heart failure, a mini-stroke, or an ischemic stroke.
- People with blood pressure that is too high or too low at the time of screening and has not been brought under control with treatment (defined as a top number of 160 or above or below 90, or a bottom number of 100 or above or below 60); people with small deviations from these limits that the trial doctor considers to be of no clinical concern may still be considered.
- People who have had serious stomach or bowel problems in the 3 months before screening (such as severe acid reflux, gastrointestinal bleeding, or stomach ulcers), or who have had surgery that could affect how medications are absorbed (such as removal of the whole stomach or all of the small bowel).
- People with other serious uncontrolled health conditions, such as active cancer, severe infections, or serious breathing problems.
- People who have a slow heart rate at rest (below 60 beats per minute) at screening that the trial doctor considers to be clinically significant.
- People whose heart's electrical activity shows a prolonged interval on an ECG test at screening or at the start of the study (above a certain threshold that differs for males and females) (confirm with trial site).
- People with kidney problems or liver problems shown in blood tests, above specified limits set by the study laboratory.
- People with thyroid function test results at screening that the trial doctor considers abnormal and unsuitable for study participation.
- People who test positive for syphilis or HIV antibodies.
- People who have recently taken certain Alzheimer's or memory-related medications before entering the study, including donanemab (within the past 2 months), lecanemab (within the past 5 weeks), or other Alzheimer's treatments or brain-boosting medications such as cholinesterase inhibitors or NMDA receptor antagonists (within the past 4 weeks).
- People who have taken part in another drug clinical trial within the past month (or within a longer period based on the study drug's specific properties, whichever is longer), or who are currently in another clinical trial.
- People who are unable to complete the required thinking and memory tests because of vision or hearing problems that cannot be corrected.
- People who are unable to complete study-required assessments due to personal limitations, such as having a medical reason they cannot have an MRI scan.
- People of childbearing potential (male or female) who are unwilling to use effective contraception from the start of the study until 6 months after it ends, or female participants of childbearing potential who are unwilling or unable to have pregnancy tests done.
- Women who are pregnant or breastfeeding.
- People who, in the trial doctor's judgement, have any other condition that makes participation in the study unsuitable.
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
Phone: +8613735826039
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
Recruiting
Phase
Phase 3
Sponsor
Wanbangde Pharmaceutical Group Co., LTD
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
15 August 2028
Primary endpoints
ADAS-Cog11; ADCS-ADL
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 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.