Alz-ID™ Alzheimer`s Health Risk Assessment Blood Test

Alz-ID™
Alzheimer’s Health
Risk Assessment
Blood Test
1. Does the Alz-ID blood test diagnose Alzheimer’s disease?
No. There is no pathological or biochemical test for Alzheimer’s disease. Alz-ID can
identify patients at risk for developing Alzheimer’s disease. Results will place patients into:
Increased risk, Average risk or Decreased risk category for developing Alzheimer’s disease.
2. What does the Alz-ID blood test measure?
Low brain levels of a certain type of phospholipids called plasmalogens are linked to
decreased mental function and increased Alzheimer’s pathology.
These special lipids are synthesized in the liver and transported to the brain. Patients with
low levels or a low capacity to make these lipids have an increased risk of developing
Alzheimer’s disease. Patients with high levels have a decreased risk of developing
Alzheimer’s disease.
3. What is Alz-ID?
Alz-ID is a quantitative measure of a person’s current plasmalogen biosynthesis status.
Levels of docosahexaenoic acid (DHA) containing ethanolamine plasmalogens (PlsEtn) and
other key plasmalogens in the blood are measured to determine a quantitative PlsEtn
biosynthesis value (PBV). PBV values are grouped into three categories: (Above Normal
PBV = decreased risk; Normal PBV = average risk; Below Normal PBV = increased risk).
The person’s PBV value is directly correlated to their risk of Alzheimer’s disease as follows:
Alz-ID Measures: Plasmalogn Biosynthesis Value (PBV)
Below Normal PBV Normal PBV
Above Normal PBV
=
= =
Increased risk of Alzheimer’s disease
Average risk of Alzheimer’s disease
Decreased risk of Alzheimer’s disease
Alz-ID™
Alzheimer’s Health
Risk Assessment
Blood Test
4. How well does the test work at predicting Alzheimer’s disease?
Alz-ID can help identify if the patient is at risk for developing Alzheimer’s disease at
a certain stage in their life. The earlier you can discover the risk status of the patient, the earlier
you can establish a possible prevention program that can delay or prevent Alzheimer’s disease
from developing.
Key Clinical Findings:
Various trials over 10,000 patients have been tested with 15 years of patient data
Table 1: Temporal cortex PlsEtn composition and cognition
Detailed post-mortem analyses of PlsEtn
PlsEtn (input) and Cognition (output)
composition was performed in 100 elderly
PlsEtn
R-Squared
Coeff.
p
persons from the Rush University Memory
and Aging Project. All persons had detailed 22:6 (DHA)
0.300
9.16
<0.00001
cognitive assessments performed within
corrected for age, gender, and education, n=100
12 months of their death. High brain levels Table.1
of DHA-PlsEtn were observed to be
strongly correlated with higher cognition. Model was corrected for age, education,
ApoE genotype, and gender.
Table 2: Serum PBV, cognition, and odds of Alzheimer’s disease
PBV was determined in the serum of 862 elderly
persons enrolled in the Rush University Memory
and Aging Project. All persons had detailed
cognitive assessments performed at the time of
blood sampling. After adjusting for age, education,
ApoE genotype, gender, and HDL-C/Total
Cholesterol, PBV was observed to be highly
correlated with cognition and odds of Alzheimer’s
Table.2
disease. The size of this effect is described by the
exp (bxSDofX) value, which allows a continuous value (PBV) to be compared to a static value
(ApoE genotype). These results show that persons with an above normal PBV have the same
decreased risk of Alzheimer’s disease as an ApoE ε2 carrier and subjects with a below normal
PBV have an increased risk of Alzheimer’s disease than an ApoE ε4 carrier.
Alz-ID™
Alzheimer’s Health
Risk Assessment
Blood Test
Table 3: Alz-ID and percent of elderly subjects
with Alzheimer’s disease
Below Normal
PBV
PBV was determined in the serum of 862 elderly
persons currently enrolled in the Rush University
Memory and Aging Project. Diagnosis of Alzheimer’s
disease was performed at time of blood sampling.
Subjects with an above normal PBV (decreased risk)
had a lower rate of Alzheimer’s disease (<3%) and
subjects with a below normal PBV (increased risk)
had a higher rate of Alzheimer’s disease (19%)
versus subjects with a normal PBV (average
risk, 9%).
The two studies presented here are representative
of several independent post-mortem and
serum-based studies linking decreased PlsEtn
with decreased cognition.
Normal
PBV
Above
Normal
PBV
Decreased
Risk
Average
Risk
Increased
Risk
Table.3
5. What does test sensitivity mean for Alz-ID?
Terms like clinical sensitivity or specificity are not appropriate for functional diseases in
which there is no pathological surrogate. The appropriate way to evaluate the
effectiveness of a particular test or risk factor is a term called attributable risk. Attributable
risk assesses the relative contribution of various causal factors to the observed prevalence.
The key risk factors for Alzheimer’s disease (other than age) are: ApoE genotype, high
triglycerides, and sub-optimal plasmalogen biosynthesis capacity. Sub-optimal plasmalogen
biosynthesis capacity accounts for up to 90% of the attributable risk of Alzheimer’s disease.
6. What does test specificity mean for Alz-ID?
Since Alzheimer’s has a 7-10 year prodromal phase, it is not possible to define a true
negative population for which to determine clinical specificity. The more correct concept
is: what percent of Alzheimer’s disease is not attributable to sub-optimal plasmalogen
biosynthesis? This is estimated to be less than 10% of the total Alzheimer’s
disease population.
Alz-ID™
Alzheimer’s Health
Risk Assessment
Blood Test
7. Can a patient’s plasmalogen levels change over time?
Yes. Overall, plasmalogen levels begin to decline starting at age 60, but not in everyone.
Longitudinal studies reveal that although there is a general decrease with age,
plasmalogen levels in some people stay the same or even increase. Lifestyle factors that
influence plasmalogen levels are being actively studied but the results of these studies
are not yet known. Although there is no cure for Alzheimer’s disease at this time, there is
increasing evidence that can influence the potential onset of disease or possibly stop the
disease from developing in the future. Diet, exercise and being mentally stimulated all
contribute to maintaining cognitive health.
8. When to start testing with Alz-ID?
At 60 years of age. Typically, testing about 10 years prior to the average onset of
Alzheimer’s disease is recommended.
9. If the patient has an increased risk Alz-ID test result, do they have
Alzheimer’s disease?
No. Alz-ID test results group the patient into three categories (decreased, average or
increased risk). If the test shows a below normal result, the patient should be motivated to
decrease their risk, starting with modifying their lifestyle in a positive way. This is similar to
newly diagnosed diabetics being told to manage their lifestyle with likely changes to diet,
exercise and mental stimulation.
A below normal result does not indicate that that the patient will develop Alzheimer’s
disease, but it does predict that they are at an increased risk based on their current
situation.
If they have a below normal result, be prepared to motivate them to make changes to their
lifestyle to keep healthy.
10. Do they need to be re-tested with Alz-ID?
If the patient had a below normal test result, (increased risk) they should be encouraged to
be re-tested at least once a year. To improve the likelihood of their result moving from
increased risk to decreased or average risk, the patient should follow their health care
provider’s recommendations for lifestyle changes, including diet, exercise and mental
(cognitive) stimulation.
Alz-ID™
Alzheimer’s Health
Risk Assessment
Blood Test
If the patient had an above normal test result (decreased risk), they should be re-tested at
least once every two years. Keeping healthy and mentally stimulated will help ensure the
patient will not become increased risk over time.
11. If a family member has Alzheimer’s disease and the patient has an increased risk
Alz-ID test result, are they at an increased risk of developing Alzheimer’s disease?
No. Some of the known risk factors for Alzheimer’s disease, when combined, result in an
increased risk. The interaction between family history and biological risk factors is not fully
understood. Again, because the patient is at increased risk, does not mean they will
develop the disease.
12. If a family member has Alzheimer’s disease and the patient has a decreased risk
Alz-ID test result, are they still at increased risk of Alzheimer’s disease?
For the majority of patients the risk is not increased.
13. Is the Alz-ID test approved for sale in Canada?
The test is approved by Health Canada as a Class II test.
Diet and lifestyle modifications have now been firmly established as being effective
at improving cognition and reducing Alzheimer’s disease risk. Furthermore, risk
reducing behavior preferentially benefits those at risk. The optimal time to reduce
your risk of Alzheimer’s disease is before symptoms appear.
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.
BC LifeLabs
Ontario LifeLabs
Ontario CML HealthCare
Kit Ordering Service
1-800-431-7206
1-877-849-3637
1-800-263-0801
1-877-990-1575
[email protected]
www.lifelabs.com
The Alz-ID™ test is intended for use in risk assessment and monitoring; it is not a standalone test, and is not a screening test for Alzheimer’s disease.
Lifelabs and LifeLabs logo are registered trademarks of LifeLabs LP. The Alz-ID™ is a trademark of Phenomenome Discoveries Inc.
and is used by under license LifeLabs LP.
ALZ004 | V.1 | MAR 2015
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