Alzheimer's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 55 or older at the time of screening.
• People who are able to give their own consent to participate, or who have a legally recognised representative who can do so on their behalf.
• People (and their study partners) who can speak and read English well enough to complete all assessments without needing an interpreter.
• People with adequate vision and hearing (glasses or hearing aids are allowed) to complete memory and thinking tests.
• People who are not currently pregnant or breastfeeding.
• People whose medications have been stable for at least 4 weeks before screening.
• People who score 5 or below on a short depression screening questionnaire (GDS-15), indicating no significant current depression.
• People who have a study partner — a family member, friend, or carer — who has known them for at least 12 months, has regular contact with them (around 10 or more hours per week, in person or by phone), and is willing to attend study visits and complete questionnaires about the participant.
• People who are willing to have a smell test, a nasal brushing procedure, and a blood draw from a vein.
• People who are willing and able to attend all study visits over the full duration of the study.

For people with no memory or thinking concerns (Cognitively Normal group), additional criteria include:

• People who have no memory or thinking concerns reported by either themselves or their study partner.
• People with no current or past diagnosis of mild cognitive impairment (MCI), Alzheimer's disease, or any other form of dementia, and no current neurological or neuropsychiatric diagnosis.
• People who score 27 or higher out of 30 on a standard cognitive screening test (MMSE) at screening.
• People who score 0 on a standard dementia rating scale (CDR) at screening, indicating no cognitive concerns.
• People whose memory performance on a standard word-recall test falls within the normal range for their age and education.

For people with Mild Cognitive Impairment (MCI), additional criteria include:

• People who themselves notice memory or thinking changes, or whose study partner has reported memory concerns.
• People who score between 24 and 30 out of 30 on the MMSE at screening.
• People who score 0.5 on the CDR scale at screening, indicating very mild cognitive changes.
• People whose memory performance on a standard word-recall test is notably below what would be expected for their age and education (1.5 standard deviations below average).
• People whose day-to-day functioning is largely preserved and who do not meet the criteria for a dementia diagnosis.

For people with Alzheimer's disease (AD), additional criteria include:

• People who have a confirmed clinical diagnosis of probable Alzheimer's disease made by a qualified specialist (such as a cognitive neurologist or geriatric psychiatrist).
• People who score between 16 and 26 out of 30 on the MMSE at screening.
• People who score 1 or higher on the CDR scale at screening.
• People whose study partner can confirm a history of gradually worsening memory or thinking over at least 6 months.
• People who show some impact on everyday activities consistent with dementia, but who are still able to participate in the study procedures.

Who may not be able to join:

• People who have a significant neurological condition other than those being studied in this trial — for example, Parkinson's disease, Lewy body dementia, frontotemporal dementia, Huntington's disease, multiple sclerosis, brain tumour, epilepsy, or significant brain injury with lasting effects (confirm with trial site for the full list).
• People who have had an active or unstable major psychiatric illness — such as schizophrenia, bipolar I disorder, or severe depression with active suicidal thoughts — within the past 6 months, or any history of schizophrenia at any point in their life.
• People who have had psychotic episodes, severe agitation, or significant behavioural problems in the past 3 months that could interfere with taking part.
• People with a current moderate or severe substance use disorder, or an alcohol use disorder within the past 24 months.
• People currently being treated for an active cancer, or whose cancer is expected to significantly limit life expectancy within 30 months (not including non-melanoma skin cancer or localised prostate cancer being monitored without active treatment).
• People who are already taking part in other studies that involve cognitive testing more than once a year.
• People who have had nasal surgery or have nasal abnormalities on both sides that could interfere with the nasal brushing procedure (this is assessed at the clinician's discretion).
• People who have had a respiratory infection (such as a cold) in the two weeks before the procedure.
• People who are known to be allergic or have had a bad reaction to local anaesthetics or nasal decongestants such as lidocaine, tetracaine, or oxymetazoline.
• People who have any other medical or psychiatric condition, or abnormal test results, that the investigator considers would make participation unsafe or unsuitable.

Additional exclusion criteria for the Cognitively Normal group only:

• People who have previously used or are currently using certain Alzheimer's medications — specifically cholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine — for any reason.
• People who have previously used or are currently using anti-amyloid treatments (such as aducanumab, lecanemab, or donanemab).

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