Alzheimer's Disease: Potential Benefit of Isoflavones

NCT00205179 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: 2003-0485K23AG024302-03A534255SMPH/MEDICINE/MEDICINE*G
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (10)

• Cognitive Outcomes - Language Executive Function : Category Fluency Assessed as Number of Words Generated/Min

  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

  6 months

• Cognitive Outcomes - Language Executive Function : Phonemic Fluency/Verbal Fluency Assessed as Number of Words Generated Per Minute

  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

  6 months

• Immediate and Delayed Recall on Verbal Memory/ List Learning Immediate and Delayed Free Recall: Number of Words Recalled

  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.

  6 months

• Immediate and Delayed Recall on Verbal Memory/ Logical Memory Immediate and Delayed Recall: Number of Story Elements Recalled

  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.

  6 months

• Measure of Divided Attention: Time to Complete Trail Making Test B

  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.

  6 months

• A Test of Planning: Time to Complete Mazes

  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.

  6 months

• Measure of Selective Attention: Time to Complete Stroop Color Word Test

  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.

  6 months

• Visual Memory Test: Complex Figure Delayed Recall; Number of Points

  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.

  6 months

• Visual Memory : Benton Visual Retention Test: Number of Correct Figures

  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.

  6 months

• Cognitive Outcomes - Visual Memory : Benton Visual Retention; Number of Errors

  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.

  6 months

Secondary Outcomes (19)

• Cognitive Outcomes - Visual Motor : Complex Figure Copy; Number of Points

  6 months

• Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Dominant Hand

  6 months

• Cognitive Outcomes - Visual Motor : Time to Complete Grooved Pegboard Test Using the Non-Dominant Hand

  6 months

• Cognitive Outcomes-Global Cognition : Mini-Mental State Examination (MMSE) Score

  6 months

• Multiple Mood States: Profile of Mood States (POMS)-Depression Scale

  6 months

Study Arms (2)

Novasoy treated

EXPERIMENTAL

100mg/day soy isoflavones

Drug: Novasoy

Placebo

PLACEBO COMPARATOR

100mg/day matching placebo

Drug: Placebo

Interventions

Novasoy DRUG

100mg/day soy isoflavones

Novasoy treated

Placebo DRUG

100mg/day matching placebo

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

• Gleason CE, Carlsson CM, Barnet JH, Meade SA, Setchell KD, Atwood CS, Johnson SC, Ries ML, Asthana S. A preliminary study of the safety, feasibility and cognitive efficacy of soy isoflavone supplements in older men and women. Age Ageing. 2009 Jan;38(1):86-93. doi: 10.1093/ageing/afn227. Epub 2008 Dec 2.

  PMID: 19054783 RESULT

• Gleason CE, Fischer BL, Dowling NM, Setchell KD, Atwood CS, Carlsson CM, Asthana S. Cognitive Effects of Soy Isoflavones in Patients with Alzheimer's Disease. J Alzheimers Dis. 2015;47(4):1009-19. doi: 10.3233/JAD-142958.

  PMID: 26401779 RESULT

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Carey Gleason
• Organization: University of Wisconsin

ceg@medicine.wisc.edu

608-280-7000

Study Officials

• Carey E Gleason, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 22, 2020
• Results First Posted: January 22, 2020

Record last verified: 2020-01

Locations

US (1)