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Baseline Differences in Long-term Survivors and Nonsurvivors of the Colorado/Columbia Fetal Implant Trial

Published online by Cambridge University Press:  14 June 2021

Cynthia McRae Open the ORCID record for Cynthia McRae [Opens in a new window] ,
Michelle Dunk ,
Dan Russell ,
Heiner Ellgring ,
Yaakov Stern ,
Paul Greene ,
Stanley Fahn  and
Claire Henchcliffe
Cynthia McRae*
Affiliation:
Morgridge College of Education, University of Denver
Michelle Dunk
Affiliation:
Department of Psychology, University of Wisconsin-Milwaukee
Dan Russell
Affiliation:
Human Development and Family Studies, Iowa State University
Heiner Ellgring
Affiliation:
Psychology Department, University of Wuerzburg
Yaakov Stern
Affiliation:
Department of Neurology, Columbia University Medical Center
Paul Greene
Affiliation:
Department of Neurology, Yale School of Medicine
Stanley Fahn
Affiliation:
Neurological Institute, Columbia University Medical Center
Claire Henchcliffe
Affiliation:
Department of Neurology, University of California, Irvine
*
*Correspondence and reprint requests to: Cynthia McRae, Morgridge College of Education, University of Denver, Denver, CO80208, USA. Email: cynthia.mcrae@du.edu
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Abstract

Objective:

This study is based on long-term follow-up of participants in a randomized double-blind sham surgery-controlled trial (1995–1999) designed to determine the effectiveness of implantation of human embryonic mesencephalic tissue containing dopamine neuron precursors into the brains of patients with advanced Parkinson’s disease (PD). We investigated differences between long-term survivors and nonsurvivors at baseline in order to contribute to information regarding optimal patient selection for upcoming stem cell trials.

Method:

Forty participants were randomly assigned to receive either neural implantation or sham surgery. Thirty-four patients who ultimately received the implant were followed periodically with the most recent assessment occurring in 2015–2016. Demographic information, neurological measures, positron emission tomography (PET) imaging, neuropsychological assessments, and a personality assessment were included in the current analyses. T-tests were used to compare survivors and nonsurvivors. Logistic regression analyses examined predictors of survivorship.

Results:

Five of six survivors were female. They were younger than nonsurvivors (p = .03) and more neuropsychologically “intact” across a broad range of cognitive areas (significance levels ranged from <.001 to .045). There were no differences between survivors and nonsurvivors off medications at baseline on neurological or PET assessments. Survivors reported more “Openness to Experience” (p = .004) than nonsurvivors. Using empirically derived predictor variables, results of logistic regression analyses indicated that Animal Naming (cognitive task) and Openness to Experience (personality variable) were the strongest predictors of survivorship.

Conclusions:

Variables to consider when selecting participants for future cell-based therapies include being “intact” neuropsychologically, level of Openness to Experience, younger age, and inclusion of women.

Keywords

Parkinson’s diseaseDouble-blind sham surgeryNeuropsychological testsFollow-up studiesCell- and tissue-based therapyOpenness to Experience
Type
Regular Research
Information
Journal of the International Neuropsychological Society , Volume 28 , Issue 5 , May 2022 , pp. 452 - 459
Copyright
Copyright © INS. Published by Cambridge University Press, 2021

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