Printed from Voxsanity (voxsanity.com.au) — NCT04701177 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Alzheimer's Disease Trial, By Invitation
NCT04701177
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 are male or female and over 45 years of age.
- People who are seen at a memory clinic or are taking part in an observational study.
- People who have a caregiver or family member available to assist and take part in the study.
- People who have been diagnosed as being on the Alzheimer's disease (AD) biological continuum, with evidence of a specific protein buildup (amyloid-beta) shown through a spinal fluid test or brain scan, along with specific scores on memory and thinking tests, as defined by international medical guidelines.
- People in the "preclinical AD" category, meaning they have a high memory test score (MMSE of 27 or above), a cognitive health rating of 0 (CDR=0), and little to no thinking difficulties — including those who notice memory changes themselves but still meet these scores.
- People in the "prodromal AD/mild cognitive impairment due to AD" category, meaning they have a memory test score above 23 (MMSE >23), a cognitive health rating of 0.5 (CDR=0.5), and measurable difficulties on a specific thinking and memory test (RBANS).
- People being assessed for early-stage Parkinson's disease (prodromal PD), who are male or female aged 60 or older — or aged 30 or older if they carry certain rare genetic mutations (such as SNCA, Parkin, or Pink1).
- People currently taking certain medications (alpha methyldopa, methylphenidate, amphetamine derivatives, or modafinil) who are willing and medically able to pause those medications for a set period before a specific brain imaging scan (DaTscan).
- People who have signed an informed consent form, along with their caregiver or informant.
- People whose informant or caregiver is able to read and communicate in the language used at the study site, and is available to actively take part in tests and questionnaires.
- People, along with their informant or caregiver, who own a smartphone.
- People who are male or female and over 45 years of age with no evidence of amyloid-beta protein buildup based on spinal fluid or brain scan results.
- People who are roughly matched in age and gender to the AD participants in the study at a group level.
- People who have an informant available to assist and take part in the study.
- People with a memory test score above 27 (MMSE >27) and a cognitive health rating of 0 (CDR=0).
- People who are generally in good health, or who have mild, well-controlled long-term conditions (such as metabolic, breathing, immune, or heart-related conditions) that do not significantly affect daily activities or social interactions.
- People who are able to read and communicate in the language used at the study site.
- People who have signed an informed consent form, along with their caregiver.
- People, along with their informant, who own a smartphone.
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 additional neurological or psychiatric condition that affects daily activities, thinking ability, or social interactions.
- People who have a clinical diagnosis of Parkinson's disease, a related movement disorder, or dementia.
- People who have taken dopamine-blocking medications (such as antipsychotics), metoclopramide, or reserpine within 6 months before the screening visit.
- People currently taking blood-thinning medications (such as warfarin/coumadin or heparin) that could make a spinal fluid (lumbar puncture) procedure unsafe.
- People with an abnormal vitamin B12 level.
- People with any other condition that significantly affects mobility, daily activities, thinking ability, or social interactions (for example, certain immune or inflammatory conditions, or recent recovery from injury or stroke).
- People with a thyroid-stimulating hormone (TSH) level above the normal range.
- People with levels of thyroid hormones T3 or T4 outside the normal range in a way that is considered clinically significant.
- People who have an additional neurological or psychiatric condition that affects daily activities, thinking ability, or social interactions.
- People with a diagnosed condition or post-traumatic situation that is not fully controlled by treatment and causes significant limitations in daily activities, thinking ability, or social interactions.
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.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
GP referral letter
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Trial details
Status
By Invitation
Phase
Not Applicable
Sponsor
Greece 2021 Committee
Registry
ClinicalTrials.gov
Start date
15 March 2021
Est. completion
30 October 2031
Where this trial is recruiting
🇬🇷 Greece
🇪🇸 Spain
Primary endpoints
Establish standardized protocols for acquisition, transfer & analysis of clinical, digital, imaging, biologic and genetic data that can be used in the AD & PD research community.; Comprehensive and uniformly acquired dataset; Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)
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.