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:

• Adults aged 55 or older, with no upper age limit, at the time of their screening appointment
• People who have been formally diagnosed with either Alzheimer's Disease, or a mixed form of dementia involving both Alzheimer's Disease and Vascular Dementia
• People who score 17 or higher on a standard memory and thinking test called the Mini Mental State Examination
• People who have had a specific blood test (pTau-217) showing a positive or intermediate result within the past 12 months, or who have had a positive brain scan or spinal fluid test confirming the presence of amyloid (a protein linked to Alzheimer's)
• People who are able to begin the trial treatment within 2 weeks of being assigned to a treatment group, with that assignment ideally happening within 4 weeks of the screening visit and no later than 8 weeks after it
• People who are willing and able to attend all treatment sessions and assessments as required by the trial schedule
• People who are willing and able to have MRI brain scans as part of the trial, unless a medical reason prevents this (such as having certain types of pacemakers, metal implants, cochlear implants, metal fragments in the body, or severe claustrophobia — the trial site can advise on which specific devices may be acceptable)
• Women who could become pregnant must have had a negative pregnancy test within 4 weeks before being assigned to a treatment group
• People whose liver is functioning normally at screening, based on specific blood test results within accepted ranges (confirm with trial site for exact values)
• People who have a "study partner" — someone they have contact with at least twice a week — who has also agreed to take part in the trial
• People being re-enrolled into the trial after previously completing 18 months of follow-up must have waited at least 12 weeks (or 6 weeks if the treatment was found to be ineffective) since their last dose before their new screening visit
• People being re-enrolled after their treatment arm was stopped due to lack of effectiveness must have waited at least 6 weeks since their last dose before their new screening visit

Study partner requirements — a study partner may be eligible to participate if they:

• Are connected to a trial participant who meets the trial's eligibility criteria and has consented to take part
• Have at least twice-weekly contact with that participant
• Are aged 18 or older at the time of giving consent
• Are willing to complete questionnaires and attend both remote and in-person study visits with the participant
• Have provided documented informed consent

Who may not be able to join:

• People whose MRI scan shows the highest level (score of 3) of a particular type of white matter change in the brain, known as a Fazekas Score of 3 (confirm with trial site regarding MRI requirements)
• People who have been diagnosed with Dementia with Lewy bodies
• People who have been diagnosed with Parkinson's disease
• People who have been diagnosed with Frontotemporal Dementia
• People with moderate to severe heart failure (classified as Stage C or D by the American Heart Association)
• People who have been hospitalised for a breathing or lung-related condition within the past 6 months
• People with significant kidney disease or reduced kidney function at any point before joining the trial (confirm with trial site for specific thresholds)
• People with an active cancer diagnosis, unless they are in complete remission (this includes solid tumour cancers, blood cancers, and melanoma)
• People who score 1 or higher on a standardised suicide risk assessment scale (C-SSRS) at their screening visit
• People who do not have an identified study partner
• People whose medication for Alzheimer's Disease or brain/mental health conditions (such as antidepressants) has been changed or had its dose adjusted within 28 days before screening
• People who have taken part in another clinical trial involving an investigational medicine or device within the past 26 weeks (with specific exceptions for people being re-enrolled in this trial)
• People who have received an antibody-based amyloid-clearing treatment for Alzheimer's Disease within the past 26 weeks
• People who are unwilling or unable to follow the study procedures
• People who are unable to swallow whole capsules
• People who live in the same household as another participant who is currently taking trial medication in this study
• Women who are pregnant or breastfeeding
• Women who could become pregnant and are unwilling or unable to use an acceptable form of contraception during the trial and for 12 weeks after the last dose of trial medication
• Male participants whose partner could become pregnant, if that partner is unwilling or unable to use an acceptable form of contraception during the trial and for 12 weeks after the last dose
• Male participants who are unwilling to avoid donating sperm during the trial and for 12 weeks after the last dose
• People who have previously received or are currently receiving any of the specific medications being tested in this trial within the past 26 weeks
• People with a history of alcohol or drug misuse or dependence within the past 5 years
• People with any other significant medical condition, abnormal test results, or uncontrolled illness that the trial doctor believes could make participation harmful
• People who are not eligible for at least one of the specific treatment options being tested in this trial, based on additional medication-specific criteria (confirm with trial site regarding Atomoxetine- and Metformin-specific requirements)

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