CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Novasoy +1 moredrug
Likely dose
Novasoy 100 mg/day soy isoflavonesAI-extracted
Key inclusion· 3
  • Diagnosis of probable Alzheimer's disease
  • Has reliable and available caregiver to assist with medication and appointments
  • On a stable dose of cholinesterase inhibitor, or not planning to re-initiate cholinergic therapies during the study
Key exclusion· 8
  • Current or recent use (<6 months) of menopausal Hormone Replacement Therapy (HRT)
  • Current or recent use (<4 months) of oral antibiotic therapy
  • Typical dietary intake of soy isoflavones >5 mg/day
  • History of significant gastrointestinal or colon disease, or colon/intestinal resection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00205179
NCT00205179Phase 2Completed

Alzheimer's Disease: Potential Benefit of Isoflavones

University of Wisconsin, Madison·interventional·Posted Sep 20, 2005·Updated Jan 22, 2020

In Brief

A Phase 2 clinical trial evaluating Novasoy and Placebo for Alzheimer's Disease. Completed, enrolled 72 participants across 1 site.

Detailed Summary

The purpose of this pilot study is to evaluate the potential effects of soy isoflavone supplements on cognitive function for men and women with Alzheimer's Disease (AD). Preliminary studies evaluating the effects of soy supplements on memory in cognitively healthy older adults have yielded promising results that are now being evaluated in patients with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 20, 2005
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

Novasoydrug

100mg/day soy isoflavones

Placebodrug

100mg/day matching placebo