Phase 2 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:

• People aged 50 to 80 years old (those aged 50 to 60 must show mild cognitive impairment at screening, not just early-stage changes)
• People who are either cognitively unimpaired (early/preclinical Alzheimer's disease with no noticeable thinking problems) or mildly impaired (early symptomatic Alzheimer's disease with only slight cognitive changes)
• People with a score between 20 and 30 on a standard memory and thinking test (MMSE), with the minimum score adjusted upward depending on years of education completed
• People whose blood test results at screening show signs of the amyloid protein buildup associated with Alzheimer's disease
• People whose brain scan (PET) shows elevated levels of tau protein in the brain above a certain threshold
• People whose brain scan (PET) shows elevated levels of amyloid protein in the brain above a certain threshold
• People who have been on stable doses of any permitted medications for at least 30 days before screening
• People who live at home or in the community, including assisted living arrangements
• People who have a study partner (such as a family member or close friend) who is willing and able to attend study visits, provide information about the participant, and spend at least 5 hours per week with the participant for the duration of the study
• People who, in the opinion of the trial doctor, are likely to be able to follow the study requirements and have sufficient vision, hearing, and reading ability in English or Spanish to complete required tests (hearing aids are permitted)
• People who have consented to all study procedures, including a genetic test for the APOE gene
• People who complete all required screening assessments

Who may not be able to join:

• Women who are pregnant or breastfeeding, or who plan to become pregnant during the study
• Women of childbearing potential who have not used a highly effective form of contraception in the 28 days before screening, or who are unwilling to use one throughout the study; and men who are sexually active with a woman of childbearing potential and are unwilling to use barrier contraception (condom with spermicide) during the study and for 6 months after the last dose, unless the female partner is using a highly effective method of contraception
• People who have poor vein access that would make multiple blood draws difficult
• People who weigh less than 40 kg (about 88 lbs) or more than 136 kg (about 300 lbs) at screening
• People with known or suspected allergies or hypersensitivity to any components of the study treatment
• People who have previously received the study treatment, unless it can be confirmed they only received a placebo in a prior study
• People currently taking or who have previously taken any medications listed as prohibited under the study protocol
• People currently enrolled in another clinical trial (those in observational studies only may be considered with additional review and approval)
• People for whom MRI scans are not safe, including those with certain metal implants, an MRI-incompatible pacemaker, or severe claustrophobia
• People whose screening MRI shows certain types of brain abnormalities, including areas of fluid buildup, bleeding, prior stroke involving a large brain region, significant blood vessel problems, brain tumours (with some exceptions for small benign findings), or other specified findings
• People for whom the specialised brain PET scans used in this study are not safe or suitable
• People participating in the optional spinal fluid (lumbar puncture) part of the study who have conditions that make a lumbar puncture unsafe, such as certain blood clotting problems, infection at the injection site, spinal arthritis, or a history of spinal injury or mass (confirm with trial site)
• People with unstable or clinically significant medical conditions likely to interfere with assessing the safety or effectiveness of the study drug, such as untreated sleep apnoea, significantly low vitamin B12 or folate, thyroid problems, or prior stroke, as judged by the trial doctor
• People with a history of severe allergic reactions, such as anaphylaxis, to vaccines, foods, or medications
• People who were hospitalised in the 30 days before screening or the start of the study
• People who have had a significant infection or major surgery within 3 months before screening
• People with a history of chronic or recurring infections considered clinically significant by the trial doctor
• People who have had a heart attack in the year before the study start date, or who have unstable chest pain or significant heart artery disease
• People with a history of cancer in the past 5 years, with exceptions for certain fully treated and cured skin cancers and early-stage prostate or breast cancers that have been completely removed
• People with a history of inflammatory neurological disorders
• People with a history or current presence of significant immune system or inflammatory conditions, including certain neurological disorders, as judged by the trial doctor
• People with a history of meningitis or related brain/spinal cord infections
• People with a history of moderate or severe traumatic brain injury
• People with uncontrolled seizures, or a history of seizures that have not been well controlled, with no seizure in the past 2 years before screening
• People with a history of certain psychiatric or neurological conditions not considered to be related to Alzheimer's disease, such as significant head injury, symptomatic stroke, Parkinson's disease, or serious blood vessel disease in the brain
• People who have met criteria for drug or alcohol abuse or dependence within the past 5 years
• People assessed as having significant suicide risk based on a standardised questionnaire, including reporting certain thoughts of suicide or suicidal behaviour in the past 6 months
• People with significantly abnormal vital signs, including a sitting blood pressure consistently above 160/90 mmHg
• People with diabetes whose blood sugar control is poor, as measured by an HbA1c level above 7.5%
• People with certain clinically significant abnormal blood test results, including low red blood cell levels, low white blood cell counts, low platelet counts, or abnormal blood clotting results, as judged by the trial doctor
• People with a known history of HIV infection
• People with a known history of hepatitis B or C
• People with other significant or unstable medical conditions that may interfere with study results, including chronic liver disease, breathing difficulties, significant kidney disease, or a heart rate that is too slow or too fast
• People with clinically significant heart rhythm abnormalities or other significant abnormalities on a heart tracing (ECG) at screening
• People who, in the opinion of the trial doctor or study leadership, are otherwise unsuitable for participation for any reason

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