Alzheimer's Disease Trial, Recruiting

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

Who might be able to join this trial:

For people with memory or thinking problems (early-onset Alzheimer's disease or other early-onset dementia group):

• A doctor has diagnosed the person with mild cognitive impairment or probable Alzheimer's disease, based on standard medical guidelines
• The person has a mild or no loss of daily functioning, based on a standard rating scale (global CDR score of 1.0 or lower)
• The person is able to give their own consent to participate, or has a legally authorised representative or guardian who can do so on their behalf
• The person is between 40 and 64 years old at the time of consenting to join
• The person has someone in their life (such as a family member, friend, or carer) who spends at least 10 hours a week with them and can report on their daily activities and thinking abilities — case-by-case arrangements may be considered by the trial site if this is not possible
• The person is willing and able to take part in ongoing study visits and assessments (a spinal fluid procedure is optional, not required)
• The person is not pregnant or breastfeeding; women must either be at least two years past menopause, have had a surgical procedure that prevents pregnancy, or have a negative pregnancy test before each brain scan
• The person is fluent in English or Spanish (for sites in the United States)
• The person is fluent in English, Spanish, Dutch, or Swedish (for sites outside the United States, depending on the site's language)

For people with normal memory and thinking (cognitively normal group):

• A doctor has assessed the person as having no significant problems with memory, thinking, or daily activities
• The person has a score of 0 on a standard functioning rating scale (global CDR), meaning no noticeable decline
• The person is able to give their own consent to participate
• The person scores between 26 and 30 on a standard memory and thinking test (MMSE); exceptions may be considered by the trial site for people with fewer than 8 years of education
• The person is between 40 and 64 years old at the time of consenting to join
• The person has someone in their life (such as a family member, friend, or carer) who spends at least 10 hours a week with them and can report on their daily activities and thinking abilities — case-by-case arrangements may be considered by the trial site if this is not possible
• The person is willing and able to take part in ongoing study visits and assessments (a spinal fluid procedure is optional, not required)
• The person is not pregnant or breastfeeding; women must either be at least two years past menopause, have had a surgical procedure that prevents pregnancy, or have a negative pregnancy test before each brain scan
• The person is fluent in English or Spanish (for sites in the United States)
• The person is fluent in English, Spanish, Dutch, or Swedish (for sites outside the United States, depending on the site's language)

Who may not be able to join:

• The person has been diagnosed with a form of dementia that is not Alzheimer's disease, based on standard clinical criteria
• Two or more close blood relatives (parents, siblings, or children) have had early-onset dementia in a pattern suggesting it runs strongly in the family, unless genetic testing has ruled out specific known gene mutations linked to inherited dementia
• The person is known to carry a specific gene mutation that causes inherited Alzheimer's disease or certain other inherited brain diseases (confirm with trial site for specific genes involved)
• The person has a medical reason why they cannot safely have a 3 Tesla MRI scan, such as claustrophobia, a pacemaker, certain metal implants or fragments in the body, or certain types of stents (confirm with trial site for the full list)
• The person has a history of any brain condition other than the one causing their dementia (exceptions may be considered by the trial site, such as seizures believed to be caused by early-onset Alzheimer's disease); headaches are generally not excluded
• A recent MRI scan has shown signs of infection, certain types of stroke, or multiple small areas of damage in the brain (a single small area may be acceptable unless it is in a location affecting thinking)
• The person has a significant or unstable physical health condition that the trial site determines could make it difficult to take part safely
• The person has had more than one nuclear medicine scan for research purposes in the past 12 months — additional approval from the trial's imaging team would be required for inclusion
• The person has taken any experimental (investigational) medication within the 30 days before joining the trial
• The person has previously taken part in a clinical trial testing a treatment aimed at amyloid or tau (proteins associated with Alzheimer's disease)
• The person is currently participating in another clinical study that involves memory and thinking tests, with some exceptions allowed at the trial site's discretion (co-enrolment in a specific national database study may be permitted)
• The person has a lifetime history of schizophrenia or a related condition, based on standard diagnostic criteria
• The person has been diagnosed with mania or bipolar disorder (with or without psychosis) in the past 12 months
• The person has had moderate or severe problems with substance misuse in the past 6 months (nicotine and caffeine are not excluded)
• The person has had suicidal behaviour in the past 12 months, or is currently experiencing thoughts of suicide
• The person is living in a 24-hour skilled nursing facility at the time of screening
• The person has certain blood clotting problems, is taking blood-thinning medications, has certain spinal conditions, or has suspected raised pressure in the brain — these factors would prevent participation in the optional spinal fluid procedure only, not the main study
• The trial site has determined the person is not suitable for any other reason

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