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- Bacopa (Bacopa monnieri)
- Microalgae (Haematococcus pluvialis)
- Cognition
- Illumina®
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Date:
09-15-2014 | HC# 041454-504
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Re: Bacopa Combination Supplement Improves Cognition and Memory in Patients with Mild Cognitive Impairment
Zanotta
D, Puricelli S, Bonoldi G. Cognitive effects of a dietary supplement made from
extract of Bacopa monnieri,
astaxanthin, phosphatidylserine, and vitamin E in subjects with mild cognitive
impairment: a noncomparative, exploratory clinical study. Neuropsychiatr Dis Treat. 2014;10:225-230.
Mild cognitive impairment (MCI) is more severe than age-related cognitive
decline, but not as severe as a diagnosis of senile dementia or Alzheimer's
disease. Early treatment of MCI may delay more severe decline. The purpose of
this prospective, noncomparative, multicenter study was to evaluate Illumina®
(Cristalfarma srl; Milan, Italy) for improving cognition in patients with MCI.
The 4 main ingredients of Illumina are bacopa
(Bacopa monnieri), astaxanthin from Haematococcus pluvialis algae,
phosphatidylserine, and vitamin E. The scientific rationale for the Illumina
formulation may be briefly summarized as follows:
- A
systematic review of clinical trials assessing bacopa found it had efficacy in
improving memory and some aspects of cognition.
- An
anti-inflammatory and antioxidant dietary carotenoid, astaxanthin is a
protective component of cell membranes which has been reported to clinically
improve cognitive functions.
- Phosphatidylserine
is a key phospholipid constituent of cell membranes that is found in especially
high concentrations in cerebral tissue; there is limited, preliminary evidence
that phosphatidylserine may reduce the risk of cognitive dysfunction.
- Vitamin
E deficiency is associated with Alzheimer's disease and MCI.
Patients
(n = 104, aged ≥ 50 years) referred to 5 outpatient clinics in Italy for forgetfulness,
disorientation, difficulty in concentrating, or other cognitive difficulties, and
diagnosed with MCI were included. MCI diagnosis was based on a mini-mental
state examination (MMSE) score of ≥ 22 and < 28 and on caregiver testimony on
cognitive symptoms. Patients were excluded if they had known current
psychiatric disorders or organic diseases that could interfere with the
cognitive status or were being treated with any psychotropic drug.
Patients
took 1 tablet/day of Illumina for 60 days. Description of the Illumina tablet
was restricted to the following information: 74 mg microalgae (Haematococcus pluvialis) dry extract 3%, 2 mg astaxanthin, 100
mg bacopa dry extract 20%, 20 mg bacosides, 30 mg phosphatidylserine extracted
from soy (Glycine max), and 30 mg
vitamin E of vegetable origin.
Cognition
was assessed with the Alzheimer's Disease Assessment Scale-cognitive subscale
(ADAS-cog) and Clock Drawing Test (CDT). ADAS-cog evaluates characteristics of
cognitive efficiency that are sensitive to deterioration, and CDT examines
planning ability and constructive skills.
No
patient reported concomitant drug use that would affect cognitive status. There
was a significant improvement in the ADAS-cog score and the CDT score from
baseline to study end (P < 0.001 for both). There was a significant
improvement on each of the 11 ADAS-cog test components (P ≤ 0.02 for all); the
largest improvements were in word recall and word recognition (measures of
memory). The largest ADAS-cog improvements were associated with the "less
compromised baseline mini-mental state examination scores." A total of 16%
of patients rated efficacy as excellent, 46% rated efficacy good, 28% rated
efficacy fair, and 10% rated efficacy as poor/of no use.
One
adverse event was reported (gastric disturbance), which led to the patient withdrawing
from the study. The patient was also taking corticosteroids. A total of 67% of
patients rated tolerability as excellent, 32% rated tolerability as good, and
1% rated tolerability as poor.
The
authors conclude that Illumina improved cognitive and mnemonic skills in
patients diagnosed with MCI. They acknowledge that the basic limitation of the trial
is the lack of a control group and say that it should be regarded as an exploratory
study. In the introduction, the authors note that data suggest that 25-30% of
patients with MCI revert to normal spontaneously. This means that without a
control group, there is no way of ascertaining how much of the improvement seen
in the study would have occurred normally, without any supplements. Other noted
limitations include the short observation period and lack of compliance assessment.
The authors deem that "further investigation of
this compound in adequately controlled, longer-term studies is warranted to
formally assess its cognitive effects in mild or moderate mnemonic-cognitive
disorders."
—Heather S. Oliff,
PhD
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