FAVORIT Ancillary Cognitive Trial

A Message to Sites

Thank you for participating in the FAVORIT ancillary study of cognitive function. Your involvement in this study will help us demonstrate the cognitive benefits of homocysteine lowering and pave the way to nutritional prevention of cognitive decline in renal transplant recipients and other high-risk groups, and in the general population.

To date, 1110 volunteers have been enrolled in the face to face testing component of the FAVORIT ancillary cognitive trial (FACT). The data collected so far has already provided valuable information on cognition in renal transplant recipients. Preliminary analyses of these data indicate that our population has above average intelligence and no loss of memory, but has significant impairment of executive function and depressive symptoms. Moreover, these impairments do not appear to be related to age. Biochemical data have not been analyzed and cross-sectional analysis of the relationship with homocysteine is planned upon completion of randomization into the parent trial. We will share more information with you when it becomes available.

About Us

The FAVORIT Ancillary Cognitive Trial (FACT) is an ancillary study of cognition in a double-blind randomized placebo controlled trial to determine the efficacy of homocysteine-lowering vitamin therapy on cognitive outcomes in renal transplant recipients.

Central Hypothesis - Our central hypothesis is that high plasma homocysteine is causally correlated with cognitive deficits and predisposes to cognitive decline over time.

Significance - FACT is expected to provide important data for improving health care for renal transplant recipients and other groups with chronic renal insufficiency. Given that renal insufficiency represents accelerated degenerative changes in vascular and possibly other systems, it is hoped that the outcome of this study will be of importance for understanding the potential of homocysteine-lowering treatment for cognitive protection in the general population.

Specific Aims

1)To determine the cognitive effect of homocysteine-lowering treatment over four years in renal transplant recipients.

Three secondary hypotheses will be tested:

A. Homocysteine-lowering treatment modifies the progression of cognitive decline.

B. The modification of cognitive decline in the face of B-vitamin supplementation is attributable to homocysteine lowering per se.

C. The association of homocysteine-lowering and cognitive function is modified by the presence or absence of manifest vascular disease (defined as the primary outcome of the FAVORIT parent trial as pooled, all-cause, incident or recurrent vascular disease).

2) To cross-sectionally evaluate the relation of baseline cognitive function to plasma homocysteine in renal transplant recipients.

The working hypothesis for this aim is that elevated plasma homocysteine predicts gradations of cognitive function in renal transplant recipients.

This aim is independent of treatment outcome and will represent the first comprehensive study of cognitive function in adult renal transplant recipients.

Study Design - The study is designed to recruit an estimated 1000 of the FAVORIT study participants. Subjects should be distributed randomly between a treatment and a placebo group of ~500 subjects in each. Cognitive function will be tested by administering a brief face to face battery of cognitive tests to consenting subjects during their regular clinic visits. Consenting subjects may also be tested over the phone with telephone interview of cognitive status.

Please find current information below on the FAVORIT ancillary trial. All files are PDF.

• Current Enrollment Criteria for the Ancillary Study

• IRB Approval Letter

• FACT IRB Approved Protocol

• Face to Face Testing Forms

• FACT - Dual Testing Consent

• FACT - Phone Testing Only

• NAART Audio Files - Column One

• NAART Audio Files - Column Two

• NAART Audio Files - Column Three

• NAART Audio Files - Column Four

• Stimulus Sheets - Block Design (Print out must contain no lines to be usable)

• FACT Recruitment Letter

• FACT Recruitment Postcard

• Recruitment Summary By Site/Month (Combined)

• Summary of Subjects by Randomization Category

• TICS Recruitment by Month/Site

• Face to Face Recruitment by Month/Site

• Recruitment Trends

To contact us:

Jean Mayer United States Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, 711 Washington Street, Boston, MA 02111

Phone: 617-556-3386 Fax: 617-556-3243 Email: Beverly Dobson