NCT00205179 · Phase 2 · COMPLETED
Alzheimer's Disease: Potential Benefit of Isoflavones
This small pilot study tested whether a soy isoflavone supplement called Novasoy, compared with a placebo, affects thinking and memory in people already diagnosed with probable Alzheimer's. It is a Phase 2 trial, meaning an early look at whether it works and is safe, not yet proven or approved.
You may qualify if
- Diagnosis of probable AD
- Has reliable and available caregiver to assist with medication and appointments
- On a stable dose of cholinesterase inhibitor, or if unable to tolerate medication, patient has no plans to re-initiate cholinergic therapies while in the study
You're excluded if
- Current or recent use (\<6 months) of menopausal Hormone Replacement Therapy (HRT)
- Current or recent use (\<4 months) or oral antibiotic therapy
- Typical dietary intake of soy isoflavones >5 mg/day
- History or significant gastro-intestinal or colon disease, or colon/intestinal resection
- Irritable bowel syndrome
- History of breast cancer, or abnormal mammogram within 12 months
- History of chronic obstructive pulmonary disease, diabetes mellitus, liver disease or unstable ischemic heart disease
- Significant neurological disease other than AD that might affect cognitive function, such as stroke, Parkinson's disease, multiple sclerosis, or serious traumatic brain injury
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2020-01-22