Alzheimer’s Disease

Alz-ID™

Alz-ID™ is a blood test for determining risk of Alzheimer’s disease. The test measures the level of a specific phospholipid, called a plasmalogen, in the blood. Plasmalogens are critical for the proper function of neurons in the brain, and levels in the blood correlate with levels in the brain. Therefore, if the Alz-ID test indicates a low level in the blood (a positive result), a person’s risk of Alzheimer’s disease is increased. Our results show that it is possible to detect this metabolic imbalance in the blood up to seven years before the first signs of cognitive impairment.

Since a reduction in plasmalogen represents increased risk of Alzheimer’s disease, restoring the levels to normal offers a new and exciting approach for prevention. We have already designed and synthesized a compound that can restore plasmalogen levels, and are currently evaluating its clinical efficacy.

Alz-ID should be used as an adjunct to other clinical and diagnostic parameters for managing patient risk. If you want to learn more about Alz-ID, have questions, or would like to obtain information materials for use in your office or distribution to your patients or clients, please contact us.

The Alz-ID™ test is intended for use in risk assessment and monitoring; it is not a standalone diagnostic test, and is not a screening test for Alzheimer’s Disease.

Alz-ID™ Clinical Studies

Our path to discovery of the role of plasmalogens in Alzheimer’s disease and the clinical story of developing our Alz-ID™ test:

Initial metabolomics discovery

Our first discovery of plasmalogens in Alzheimer’s disease was made when we performed non-targeted metabolomics profiling of serum samples from 256 Alzheimer’s patients and 68 controls (PrecisionMed Inc.). We used multivariate statistics to identify a cluster of metabolites that we identified as the vinyl-ether phosphoethanolamines. Using a tandem mass spectrometry-based method on the same samples, we confirmed a strong correlation between a specific plasmalogen (containing DHA) and degree of advancing dementia, with the most severely impaired patients showing an approximate 50% reduction (p<0.001).

Post-mortem validation

In this study, we analyzed DHA-plasmalogen levels in serum from 20 confirmed Alzheimer’s disease patients and 19 controls collected post-mortem (provided by Sun Health). Alzheimer’s disease patients with confirmed amyloid deposits showed an approximate 45% reduction in serum DHA-plasmalogen compared to controls with no amyloid deposits (p<0.005).

Pre-mortem validation

In this study, serum was collected and analyzed from 50 patients who were later confirmed to have varying degrees of dementia of the Alzheimer’s type upon post-mortem examination (provided by Case Western University). There was a strong correlation between DHA-plasmalogen levels and increasing dementia (based on the Clinical Dementia Rating (CDR) scale), and in confirmed Alzheimer’s disease patients, DHA-plasmalogen levels were approximately 53% reduced compared to normal subjects (p<0.0001).

Validation in Japanese patients

To verify that the plasmalogen association with Alzheimer’s disease was independent of ethnicity and geography, we recruited serum from 80 Japanese patients (from Osaka University) with probable dementia of the Alzheimer’s type (according to NINCDS-ADRDA criteria) and 80 subjects with no dementia. Serum DHA-plasmalogen levels in the Japanese Alzheimer’s disease patients were reduced by approximately 25% (p<0.0005).

Predictive validation

In this study, we further investigated the correlation between ADAS-Cog test scores (the Alzheimer’s disease assessment scale-cognitive test) and circulating levels of DHA-plasmalogen. The study included 40 Alzheimer’s disease patients who had baseline and one-year ADAS-Cog tests. The results showed that ADAS-Cog scores increased significantly (meaning increased dementia) in patients with low plasmalogen levels. The findings further substantiated a link between low plasmalogens and cognitive decline.

Longitudinal validation with Rush University

We have an extensive collaboration with Rush University – one of the leading institutes for Alzheimer’s disease research. The Memory and Aging study includes nearly 10,000 samples collected at various times from subjects over a 15-year period. These subjects showed no cognitive impairment when they enrolled and subsequently developed dementia. We have analyzed a subset of the samples and showed that peroxisomal output (the cellular organelles that make plasmalogens) is highly predictive of risk for Alzheimer’s disease. Preliminary results also indicate that subjects with the APOE4 genotype and high peroxisomal function have a low risk.