Phase 3 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:

For people with mild cognitive impairment (MCI):

• People diagnosed with mild cognitive impairment thought to be caused by chronic traumatic encephalopathy (a brain condition linked to repeated head injuries) who are older than 45, or mild cognitive impairment thought to be caused by Alzheimer's disease who are older than 50
• People who have a "trial partner" — someone who interacts with them frequently (roughly 3–4 or more times per week), can attend all clinic visits, and can help them follow the trial's procedures
• People (or their legal representative, if applicable) who are able to give informed consent as required by the trial's ethics board
• Female participants who have either had a surgical procedure that prevents pregnancy, have not had a period for at least one year, or have a negative blood pregnancy test
• People who are willing to follow all trial procedures and communicate with trial staff
• People willing to attend follow-up visits at 1 and 2 years after the imaging visit (for one part of the trial only)
• People who score 0.5 on a standard memory and thinking assessment scale (CDR global score)

Additional criteria for MCI thought to be caused by chronic traumatic encephalopathy (CTE):

• People whose symptoms have lasted longer than 2 years, with no other brain condition more likely to explain all the symptoms
• People with a history of repeated head trauma (including concussions, or even repeated smaller impacts that did not cause obvious concussion)
• People whose condition has been getting gradually worse over time, with symptoms that began after a delay following the head trauma
• People with confirmed memory and thinking difficulties across more than one area (such as memory, spatial awareness, or language), shown through formal cognitive testing
• People who also show at least one of the following: emotional difficulties (such as depression, anxiety, aggression, or relationship problems); behavioural changes (such as poor impulse control, apathy, or personality change); or physical movement problems (such as tremor, stiffness, or balance issues)

Additional criteria for MCI thought to be caused by Alzheimer's disease:

• People diagnosed with MCI due to suspected Alzheimer's disease according to standard national medical guidelines (NIA-AA criteria)
• People with documented gradual memory decline lasting at least one year (a family member or close contact may provide supporting information if no medical records are available)
• People who score between 22 and 30 (inclusive) on a standard cognitive screening test (MMSE-2) at the screening visit
• People whose blood test results show a positive marker associated with Alzheimer's disease, based on a set measurement level used by the trial
• People who score below 4 on a scale used to assess whether blood vessel problems in the brain may be contributing to their symptoms (Modified Hachinski Ischemic Score)
• People whose cognitive difficulties do not occur only during episodes of confusion (delirium)
• People whose cognitive difficulties are not better explained by another mental health condition or medical condition
• People who have been on a stable dose of standard Alzheimer's medications (acetylcholinesterase inhibitors and/or memantine) for at least 4 months before the screening visit and are expected to remain on that stable dose throughout the trial — or people who are not taking these medications due to medical reasons or previous treatment failure, and are not expected to take them during the trial

For healthy volunteers (one part of the trial only):

• People who are in good general health, within 3 years of age of a participant with MCI in the same part of the trial, and with no significant findings on physical examination or lab results
• People who have a trial partner who interacts with them frequently (roughly 3–4 or more times per week), can attend all clinic visits, and can help with trial procedures
• People with no cognitive impairment, as assessed through cognitive testing and reviewed by the trial investigator
• People with no close family members (parents, siblings, or children) who developed Alzheimer's disease or another brain-degenerating condition before the age of 65
• People who score 27 or above on the standard cognitive screening test (MMSE-2)

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who are unable to remain still during imaging procedures, or who cannot tolerate brain scanning or psychological testing (for example, due to severe head tremors, uncontrolled psychosis, or acute risk of self-harm)
• People who have had a stroke, mini-stroke (TIA), seizures, or another condition affecting the head or neck in the 12 months before the screening visit that might affect blood flow to the brain or affect how scan images are interpreted
• People with a pre-existing major neurological condition or serious physical illness that could affect the trial results (for example, multiple sclerosis, diabetes, or cancer)
• People with a psychiatric condition such as mania, schizophrenia, significant anxiety, or depression (as measured by a standard depression scale score of 10 or above) that, in the investigator's opinion, might interfere with completing trial procedures
• People whose personal situation or condition, in the investigator's opinion, might prevent the collection of complete, good-quality data
• People with a history of significant misuse of prescription drugs, non-prescription drugs, or alcohol, including substances such as marijuana, cocaine, heroin, or related substances
• People who have previously received the trial's imaging drug (F-18 FNT), or who have taken any other investigational (experimental) drug within the past 30 days
• People with a history of allergic reactions to albumin, or who have severe anaemia or heart failure that would make the use of albumin medically unsafe
• People with unstable heart disease or poorly controlled high blood pressure (systolic blood pressure above 170 mmHg or diastolic above 100 mmHg)
• People who have taken benzodiazepine medications (a type of sedative) within 24 hours before any trial visit
• People who plan to take ibuprofen or naproxen within 5 days before the PET scan
• People who have received radioactive drugs or scans within the previous month (or within 10 half-lives of the drug, whichever is longer), or who have taken part in imaging or other research studies that might affect the trial results
• People who have implanted medical devices (such as a pacemaker, insulin pump, certain metal implants, or brain stimulators), a history of claustrophobia in MRI scanners, or any other reason they cannot have an MRI scan
• People with a history of CT or MRI scan findings (such as a brain mass or brain infection) unrelated to the trial condition
• People who have taken part in another clinical trial for an experimental drug (other than a monoclonal antibody) and received at least one dose (unless confirmed as placebo) within the 90 days before the screening visit
• People who have received a monoclonal antibody treatment within the 180 days before the screening visit
• People who plan to receive aducanumab, lecanemab, or other newly approved treatments for early Alzheimer's disease during the trial

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