Alzheimer's Disease: Potential Benefit of Isoflavones

NCT00205179, Phase 2, Completed, University of Wisconsin, Madison; results first posted 2020-01-22

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	Alzheimer's Disease: Potential Benefit of Isoflavones	ClinicalTrials.gov
NCT number	NCT00205179	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Phase 2	ClinicalTrials.gov
Enrollment	72 participants, actual	ClinicalTrials.gov
Lead sponsor	University of Wisconsin, Madison	ClinicalTrials.gov
Conditions	Alzheimer's Disease	ClinicalTrials.gov
Interventions	Novasoy, Placebo	ClinicalTrials.gov
First posted	2005-09-20	ClinicalTrials.gov
Last updated	2020-01-22	ClinicalTrials.gov
Results first posted	2020-01-22	ClinicalTrials.gov

Registered outcomes 29

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min	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	ClinicalTrials.gov
Primary	Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute	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	ClinicalTrials.gov
Primary	Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled	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 delay of approximately 20 minutes, participants are asked to freely recall items from the original word list. A delayed recall score is then derived from this test.	ClinicalTrials.gov
Primary	Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled	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 details recalled.	ClinicalTrials.gov
Primary	Measure of Divided Attention: Time to Complete Trail Making Test B	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.	ClinicalTrials.gov
Primary	A Test of Planning: Time to Complete Mazes	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.	ClinicalTrials.gov
Primary	Measure of Selective Attention: Time to Complete Stroop Color Word Test	6 months	Selective attention was evaluated with the Stroop Color Word Interference Test. In the interference portion of this test, the subject identifies the color of ink in which words ("red", "green", or "blue") are printed, requiring the subject to inhibit their natural tendency to read the word. A subject's score is the time taken to identify 50 stimulus items. The time taken to complete the maze is inversely proportional to the cognitive function.	ClinicalTrials.gov
Primary	Visual Memory Test: Complex Figure Delayed Recall; Number of Points	6 months	Visual memory will be evaluated by complex figure delayed recall test. In this test , a two dimensional figure is shown to the subjects. After a delay of 30 min, they are asked to draw the same figure based on their memory. The Complex Figure Test assesses the subject's ability to remember a 2-dimensional figure presented briefly. The scoring system used includes scores related to location, accuracy and organization. Higher score correlates to better visual memory.	ClinicalTrials.gov
Primary	Visual Memory : Benton Visual Retention Test: Number of Correct Figures	6 months	The Benton Visual Retention Test (or simply Benton test or BVRT) is an individually administered test for people aged from 8 years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory. The individual examined is shown 10 designs, one at a time, and asked to reproduce each one as exactly as possible on plain paper from memory. The test is untimed, and the results are professionally scored by form, shape, pattern, and arrangement on the paper. For the 'test of number of correct figures' score is calculated based on an all-or-nothing approach; points are awarded if the reproduction of the design matches the original.	ClinicalTrials.gov
Primary	Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors	6 months	The Benton Visual Retention Test is an individually administered test for people aged from 8 years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory. The individual examined is shown 10 designs, one at a time, and asked to reproduce each one as exactly as possible on plain paper from memory. The test is untimed, and the results are professionally scored by form, shape, pattern, and arrangement on the paper. For the 'test of number of errors' score is calculated based on the number and type of errors made for each design. The major categories for these errors are omissions, distortions, perseverations, rotations, misplacements, and size errors.These scores are then be compared to several sets of normative data available in the manual, each representing different demographic characteristics, and conclusions can be drawn by the examiner.	ClinicalTrials.gov
Secondary	Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points	6 months	Visual memory will be evaluated by Complex Figure copy test. The Complex Figure Test assesses the subject's ability to copy a 2-dimensional figure. The scoring system used include scores related to location, accuracy and organization. Higher score correlates to better visual memory.	ClinicalTrials.gov
Secondary	Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand	6 months	The Grooved Pegboard is a dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key on one side must be rotated to match the hole before they can be inserted. Participants are instructed to place all pegs into the 25 holes, picking up one at a time, and using just one hand. They use their dominant hand. Time taken to finish the test inversely correlates to the cognitive ability.	ClinicalTrials.gov
Secondary	Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand	6 months	The Grooved Pegboard is a dexterity test consisting of 25 holes with randomly positioned slots. Pegs with a key on one side must be rotated to match the hole before they can be inserted. Participants are instructed to place all pegs into the 25 holes, picking up one at a time, and using just one hand. They use their non-dominant hand. Time taken to finish the test inversely correlates to the cognitive ability.	ClinicalTrials.gov
Secondary	Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score	6 months	During the MMSE, a health professional asks a participant a series of questions designed to test memory, ability to solve simple problems and other thinking skills. The maximum MMSE score - 30 points. Score of 20 to 24 - mild dementia, 13 to 20 - moderate dementia, and \<12 indicates severe dementia. On average, the MMSE score of a person with Alzheimer's declines about 2 to 4 points each year.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Depression Scale	6 months	Depression scale is one of the subscale of POMS. Depression scale has 15 items and scores ranges from 0-60. Higher score indicates more severe depression.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Tension Scale	6 months	Tension scale is one of the subscale of POMS. Tension scale has 9 items and scores ranges from 0-36. Higher score indicates more severe outcomes.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Anger Scale	6 months	Anger scale is one of the subscale of POMS. Tension scale has 12 items and scores ranges from 0-48. Higher score indicates more anger issues.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Fatigue Scale	6 months	Fatigue scale is one of the subscale of POMS. Tension scale has 7 items and scores ranges from 0-28. Higher score indicates more fatigue.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Vigor Scale	6 months	Vigor scale is one of the subscale of POMS. Vigor scale has 8 items and scores ranges from 0-32. Higher score indicates more severe outcomes.	ClinicalTrials.gov
Secondary	Multiple Mood States: Profile of Mood States (POMS)-Confusion Scale	6 months	Confusion scale is one of the subscale of POMS. Confusion scale has 7 items and scores ranges from 0-28. Higher score indicates more severe outcomes.	ClinicalTrials.gov

Outcomes 29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as	Source
PRIMARY	Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min	6 months	number of words generated per minute	MEAN	ClinicalTrials.gov
PRIMARY	Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute	6 months	number of words generated per minute	MEAN	ClinicalTrials.gov
PRIMARY	Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled	6 months	Number of words recalled	MEAN	ClinicalTrials.gov
PRIMARY	Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled	6 months	Number of story elements recalled	MEAN	ClinicalTrials.gov
PRIMARY	Measure of Divided Attention: Time to Complete Trail Making Test B	6 months	Seconds	MEAN	ClinicalTrials.gov
PRIMARY	A Test of Planning: Time to Complete Mazes	6 months	Seconds	MEAN	ClinicalTrials.gov
PRIMARY	Measure of Selective Attention: Time to Complete Stroop Color Word Test	6 months	Seconds	MEAN	ClinicalTrials.gov
PRIMARY	Visual Memory Test: Complex Figure Delayed Recall; Number of Points	6 months	number of points	MEAN	ClinicalTrials.gov
PRIMARY	Visual Memory : Benton Visual Retention Test: Number of Correct Figures	6 months	number of correct figures	MEAN	ClinicalTrials.gov
PRIMARY	Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors	6 months	Number of errors	MEAN	ClinicalTrials.gov
SECONDARY	Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points	6 months	number of points	MEAN	ClinicalTrials.gov
SECONDARY	Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand	6 months	time in seconds	MEAN	ClinicalTrials.gov
SECONDARY	Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand	6 months	time in seconds	MEAN	ClinicalTrials.gov
SECONDARY	Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Depression Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Tension Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Anger Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Fatigue Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Vigor Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Multiple Mood States: Profile of Mood States (POMS)-Confusion Scale	6 months	score on a scale	MEAN	ClinicalTrials.gov

Results by group 64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min	Placebo	21.5	Standard Error 1.9	number of words generated per minute	ClinicalTrials.gov
Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min	Novasoy	25.7	Standard Error 2.0	number of words generated per minute	ClinicalTrials.gov
Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute	Placebo	25.9	Standard Error 2.4	number of words generated per minute	ClinicalTrials.gov
Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute	Novasoy	35.2	Standard Error 2.4	number of words generated per minute	ClinicalTrials.gov
Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled	Placebo	1.8	Standard Error 0.50	Number of words recalled	ClinicalTrials.gov
Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled	Novasoy	2.2	Standard Error 0.50	Number of words recalled	ClinicalTrials.gov
Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled	Placebo	4.6	Standard Error 0.95	Number of story elements recalled	ClinicalTrials.gov
Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled	Novasoy	5.7	Standard Error 0.9	Number of story elements recalled	ClinicalTrials.gov
Measure of Divided Attention: Time to Complete Trail Making Test B	Placebo	95.5	Standard Error 16.7	Seconds	ClinicalTrials.gov
Measure of Divided Attention: Time to Complete Trail Making Test B	Novasoy Treated	95.7	Standard Error 16.0	Seconds	ClinicalTrials.gov
A Test of Planning: Time to Complete Mazes	Placebo	32.2	Standard Error 5.3	Seconds	ClinicalTrials.gov
A Test of Planning: Time to Complete Mazes	Novasoy	22.6	Standard Error 5.4	Seconds	ClinicalTrials.gov
Measure of Selective Attention: Time to Complete Stroop Color Word Test	Placebo	105	Standard Error 12	Seconds	ClinicalTrials.gov
Measure of Selective Attention: Time to Complete Stroop Color Word Test	Novasoy	91.8	Standard Error 12	Seconds	ClinicalTrials.gov
Visual Memory Test: Complex Figure Delayed Recall; Number of Points	Placebo	10.6	Standard Error 1.8	number of points	ClinicalTrials.gov
Visual Memory Test: Complex Figure Delayed Recall; Number of Points	Novasoy	13.4	Standard Error 1.8	number of points	ClinicalTrials.gov
Visual Memory : Benton Visual Retention Test: Number of Correct Figures	Placebo	2.7	Standard Error 0.4	number of correct figures	ClinicalTrials.gov
Visual Memory : Benton Visual Retention Test: Number of Correct Figures	Novasoy	2.8	Standard Error 0.4	number of correct figures	ClinicalTrials.gov
Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors	Placebo	14.5	Standard Error 1.2	Number of errors	ClinicalTrials.gov
Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors	Novasoy	13.1	Standard Error 1.2	Number of errors	ClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Novasoy	32	ClinicalTrials.gov
Overall Study	STARTED	Placebo	33	ClinicalTrials.gov
Overall Study	COMPLETED	Novasoy	30	ClinicalTrials.gov
Overall Study	COMPLETED	Placebo	29	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Novasoy	2	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Placebo	4	ClinicalTrials.gov

Adverse events 8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events	Source
other	other illness not related to treatment	General disorders	Active	25	32	25	ClinicalTrials.gov
other	other illness not related to treatment	General disorders	Placebo	23	33	23	ClinicalTrials.gov
serious	Death	Nervous system disorders	Active	0	32	0	ClinicalTrials.gov
serious	Death	Nervous system disorders	Placebo	2	33	2	ClinicalTrials.gov
serious	Seizures	Nervous system disorders	Active	1	32	1	ClinicalTrials.gov
serious	Seizures	Nervous system disorders	Placebo	0	33	0	ClinicalTrials.gov
serious	DVT	Blood and lymphatic system disorders	Active	0	32	0	ClinicalTrials.gov
serious	DVT	Blood and lymphatic system disorders	Placebo	1	33	1	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Active			ClinicalTrials.gov
Total, all-cause mortality	Placebo			ClinicalTrials.gov
Total, other adverse events	Active	25	32	ClinicalTrials.gov
Total, other adverse events	Placebo	23	33	ClinicalTrials.gov
Total, serious adverse events	Active	1	32	ClinicalTrials.gov
Total, serious adverse events	Placebo	3	33	ClinicalTrials.gov

Papers 2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19054783	RESULT	PubMed
26401779	RESULT	PubMed

Grants 1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
K23AG024302	Alzheimer's Disease: Potential Benefit of Isoflavones	GLEASON, CAREY E	UNIVERSITY OF WISCONSIN-MADISON	NATIONAL INSTITUTE ON AGING	2004 to 2008	NIH RePORTER

Trial comparisons 2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Novasoy vs Placebo: Number of Participants With ApoE4 Allele	Trial comparisons
Active vs Placebo: serious adverse events	Trial comparisons

Tests 7

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Category Fluency	Primary outcome	ConductCognition
Complex Figure Copy and Recall	Primary outcome	ConductCognition
Delayed Recall Module	Primary outcome	ConductCognition
Short Story Recall	Primary outcome	ConductCognition
Stroop Color-Word Test	Primary outcome	ConductCognition
Trail Making Test B	Primary outcome	ConductCognition
Verbal Fluency	Primary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)