NCT00205179

Alzheimer's Disease: Potential Benefit of Isoflavones

Completed Phase 2 Results posted Last updated 13 January 2020

What this trial tests

Phase 2 trial testing Novasoy in Alzheimer's Disease in 72 participants. Completed in 1 December 2009.

Timeline

1 January 2005

Primary endpoint
1 December 2009

1 December 2009

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	1 January 2005
Primary completion	1 December 2009
Estimated completion	1 December 2009
Sites	1 location across United States

Drugs / interventions tested

• Novasoy — full drug profile →
• Placebo

Conditions studied

• Alzheimer's Disease — all drugs for Alzheimer's Disease →

Sponsor

University of Wisconsin, Madison

Who can join

55 and older, any sex, with Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min
  Time frame: 6 months
  Participants are given 1 min to produce as many unique words as possible within a category (category fluency). More words per minute will correlates to better category fluency
• Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute
  Time frame: 6 months
  Participants are given 1 min to produce as many words as possible starting with a given letter (letter fluency). More number of words per minute correlates to better phonemic fluency/verbal fluency
• Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled
  Time frame: 6 months
  List of 15 semantically unrelated words is presented verbally to the participants once, after which they are asked to free recall as many words as possible. Subsequently, this presentation-test routine (learning trials) is repeated four more times. A total recall score is determined by adding the number of recalled items for the five learning trials. After presentation of a distractor list and a d
• Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled
  Time frame: 6 months
  In the logical delayed memory test, participants are read a logically organized story. Approximately 20 minutes later, the participants are asked to recall the story from memory (Delayed Recall). The version used in this study uses only one story (Story A) read once to participants at each study visit. Possible scores for delayed recall trials range from 0 to 25, with higher scores reflecting more
• Measure of Divided Attention: Time to Complete Trail Making Test B
  Time frame: 6 months
  Trail Making Test-Version B (TMT B) \[113\], a measure of divided attention, the subject is asked to draw lines to connect consecutively numbered and lettered circles, alternating between the 2 sequences. The time needed to complete the task is recorded. More time taken to complete the test or higher score indicates lower executive function/higher impairment.
• A Test of Planning: Time to Complete Mazes
  Time frame: 6 months
  Time to complete mazes is a test of planning. Subjects are asked to complete a set of 3 mazes. The time taken to complete the maze is inversely proportional to the cognitive function.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural products as a source of Alzheimer's drug leads.
   Williams P, Sorribas A, Howes MJ. · · 2011 · cited 232× · PMID 21072430 · DOI 10.1039/c0np00027b
2. Insights into the Pathogenesis of Neurodegenerative Diseases: Focus on Mitochondrial Dysfunction and Oxidative Stress.
   Jurcau A. · · 2021 · cited 89× · PMID 34769277 · DOI 10.3390/ijms222111847
3. Antiageing strategy for neurodegenerative diseases: from mechanisms to clinical advances.
   Jiang Q, Liu J, Huang S, Wang XY, et al · · 2025 · cited 74× · PMID 40059211 · DOI 10.1038/s41392-025-02145-7
4. The Role of Natural Antioxidants in the Prevention of Dementia-Where Do We Stand and Future Perspectives.
   Jurcau A. · · 2021 · cited 36× · PMID 33498262 · DOI 10.3390/nu13020282
5. Nutritional and Pharmacological Strategies to Regulate Microglial Polarization in Cognitive Aging and Alzheimer's Disease.
   Peña-Altamira E, Petralla S, Massenzio F, Virgili M, et al · · 2017 · cited 30× · PMID 28638339 · DOI 10.3389/fnagi.2017.00175
6. Targeting Ubiquitin-Proteasome Pathway by Natural Products: Novel Therapeutic Strategy for Treatment of Neurodegenerative Diseases.
   Momtaz S, Memariani Z, El-Senduny FF, Sanadgol N, et al · · 2020 · cited 28× · PMID 32411012 · DOI 10.3389/fphys.2020.00361
7. Daidzein from Dietary Supplement to a Drug Candidate: An Evaluation of Potential.
   Ubaid M, Salauddin, Shadani MA, Kawish SM, et al · · 2023 · cited 23× · PMID 37780202 · DOI 10.1021/acsomega.3c03741
8. Modulatory Effects of Phytochemicals on Gut-Brain Axis: Therapeutic Implication.
   Jaberi KR, Alamdari-Palangi V, Savardashtaki A, Vatankhah P, et al · · 2024 · cited 21× · PMID 38939650 · DOI 10.1016/j.cdnut.2024.103785