Shri Ram Chandra Mission Essay Competition 2015 Results Of Belmont

Fisher Alzheimer's Program & Clinical Core/New York University Alzheimer's Center, New York, New York, United States

Background: There is increasing recognition that clinical symptoms of Alzheimer's disease (AD) begin many years, even decades, prior to the onset of manifest mild dementia. The Global Deterioration Scale (GDS) (Reisberg, et al., Am J Psychiatry, 1982) identifies 3 pre-dementia stages. The first of these (GDS stage 3) is a stage of subtle, but observable, cognitive deficits. The terminology “Mild Cognitive Impairment,” (MCI) was coined for this GDS 3 stage in 1988 (Reisberg, et al., Drug Dev Res, 1988), and this entity has subsequently been widely studied. We initially estimated that the MCI stage lasts a mean of ∼7 years prior to the advent of the mild dementia of AD (Reisberg, Geriatrics, 1986). Subsequent studies in memory clinic populations have supported this temporal estimate (see Bruscoli and Lovestone, Int Psychogeriatr, 2004, for a review). The GDS also identifies a second pre-dementia stage, the pre-MCI stage in which older persons have subjective symptoms of cognitive deficit only and perform normally on psychometric and other measures. This GDS 2 stage is defined succinctly with the scale as: “Subjective complaints of memory deficit, most frequently in the following areas: (a) forgetting where one has placed familiar objects; (b) forgetting names one formerly knew well.” The scale also notes that in this GDS 2 stage there is, “no objective evidence of memory deficit on clinical interview,” and “no objective deficit in employment or social situations.” It is also noted that there is “appropriate concern with respect to symptomology.” We suggested the terminology “Subjective Cognitive Impairment,” (SCI) for this GDS 2 stage and estimated in 1986 that it lasts a mean of ∼15 years prior to the onset of MCI (Reisberg, Geriatrics, 1986). An 8.9 year longitudinal study in healthy subjects at baseline strongly supported this temporal estimate (Prichep, et al., Neurobiol Aging, 2006; Reisberg and Gauthier, Int Psychogeriatr, 2008). Assuming a uniformly distributed baseline subject population, and a stage lasting precisely 15 years, with uniform progression rates within the stage, then 6.667% of subjects should progress annually to MCI or dementia. On an annual basis, the difference between the 1986 estimated rate of progression and the observed percentage of subjects who advanced was only 0.23% per annum. In another investigation, a 7 year longitudinal study in healthy older persons at baseline, it was found that the hazard ratio for decline was 4.5 for SCI persons in comparison with matched GDS stage 1 persons with No Cognitive Impairment (NCI), the third pre-dementia stage (Reisberg, et al., Alzheimers Dement, 2010). This 4.5 hazard ratio was obtained after controlling for baseline demographic variables and follow-up time. Herein, we report changes in SCI (GDS stage 2) persons over a 2 year interval, a time interval of relevance for future pharmacologic trials endeavoring to slow cognitive deterioration in SCI persons.

Methods: Healthy subjects with SCI (GDS stage 2) from our published 7 year longitudinal study, with follow-ups between 1.5 and 3.0 years were selected. This resulted in a 98 subject cohort followed over 2.13 ± 0.30 years (63 women, 35 men). Baseline subject characteristics included a mean age of 67.12 ± 8.75 years (range 40 to 87 years) and a mean of 15.55 ± 2.60 years of formal education (range 8 to 21 years). The mean baseline Mini Mental Status Examination (MMSE, Folstein, et al., J Psychiatr Res, 1975) score was 28.92 ± 1.23 (range 25 to 30). To calculate the change in GDS stage, the following a priori assumptions were posited: (1) a reversion to a prior stage (i.e., improvement to NCI) = -1; (2) no stage change = 0; and (3) progression to MCI or dementia = +1.

Results: The Wilcoxon test was used for all analyses. The GDS stage changed from 2.00 at baseline to a mean of 2.16 ± 0.59 at follow-up (P < 0.01). More specifically, at follow-up, 8 subjects (8.16%) remitted to a GDS stage of 1 (NCI), 68 subjects (69.39%) remained at GDS stage 2 (SCI), 20 subjects (20.41%) declined to GDS stage 3 (MCI), and 2 subjects (2.04%) had mild dementia at follow-up. Using the methodology described above, for a uniformly distributed baseline population, the estimated annual progression rate for a stage lasting precisely 15 years (i.e., 6.667% of subjects progressing to MCI or dementia per annum), and the observed annual progression rate of GDS stage 2 subjects of 6.707%, differed by only 0.04%. Subject age was strongly positively associated with GDS change (P = 0.002). There was no association between subject gender or years of education and the GDS stage at follow-up in this predominantly well-educated cohort. After adjusting for baseline subject age, GDS progression at follow-up remained significant (P < 0.01).

Conclusions: In this healthy subject population with SCI, the GDS scale identifies a subject population which progresses at a remarkably consistent rate of ∼6.67% per annum towards MCI or, in a few cases, dementia, over a 2 year period. These results are consistent with our prior 8.9 year published longitudinal study findings. They are also consistent with a recent meta-analysis of 11 studies (including 2 of ours), of “older people with subjective memory complaints” which found an annual conversion rate to MCI of 6.67% (95% CI = 4.70 – 8.95%) (Mitchell, et al., Acta Psychiatr Scand, 2014). These results are of immediate relevance for the selection of both subject populations and outcome measures for pharmacologic and other prevention trials which are being undertaken in efforts to prevent decline in the pre-MCI, SCI stage of eventual AD.

Keywords: Subjective Cognitive Impairment, Prevention of Alzheimer's disease, Global Deterioration Scale, Treatment Outcome Prediction, Preclinical Trial Methodology

Disclosures: I am the author and copyright holder of the assessment measure which is described in this research study. This measure is made freely available for all educational and governmental purposes. Private entities may be charged for usage of this measure.

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