Supplementation with ProdromeNeuro was observed to elevate DHA-plasmalogens in a dose-dependent manner and to improve cognition (p=1.8e-02) and mobility (p=2.9e-05) in persons diagnosed with mild to moderate dementia.
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ProdromeNeuro is a plasmalogen supplement designed to specifically elevate DHA plasmalogen levels. An escalating dose study was performed in 22 persons (11M/11F) diagnosed with various degrees of cognitive impairment to determine the optimal dose for elevating blood plasmalogen levels.
Participants were clinically evaluated for cognition and mobility at baseline and after each month of supplement dosing. Cognitive status was evaluated using the Quick Dementia Rating System (QDRS), which was used to derive the participant’s Clinical Dementia Rating (CDR) score. Mobility was evaluated using the 30 second sit-stand test. Blood samples were collected for plasmalogen analyses at each clinical visit.
The escalating dosing of ProdromeNeuro was performed as follows:
Month 1 – 1ml/day (900mg/day – one bottle of ProdromeNeuro)
Month 2 – 2ml/day (1800mg/day – two bottles of ProdromeNeuro)
Month 3 – 2ml/day (1800mg/day – two bottles of ProdromeNeuro)
Month 4 – 4ml/day (3600mg/day – four bottles of ProdromeNeuro)
Month 5 – 0ml/day (0mg/day – zero bottles of ProdromeNeuro)
Blood DHA-Plasmalogen levels were observed to be increased in all participants in a dose-dependent manner. After month 1 there was a 30% increase, after months 2 and 3 there was a 60% increase and after month 4 there was a 90% increase in the target DHA-plasmalogen levels. Persons with low baseline DHA-plasmalogen levels (quartiles 1 and 2) experienced a greater increase in blood DHA-plasmalogen levels (50%, 90%, and 120%, respectively). When blood DHA-plasmalogen levels were expressed relative to an endogenous non-DHA phosphatidylethanolamine, the relative increase in the target DHA plasmalogen levels was more pronounced.
The CDR score divides participants into questionable or very mild dementia (0.5), mild dementia (1), moderate dementia (2), or severe (3). Of the 22 participants, 14 had a baseline CDR of 0.5, four had a CDR of 1 and four had a CDR of 2. Of the four participants with moderate dementia (CDR 2), two improved to a CDR of 1 and one improved to a CDR of 0.5 and one participant progressed from a CDR of 2 to a 3. In the participant that declined significant negative non-trial related live events occurred in their life during the trial. Of the four participants with mild dementia (CDR 1), two improved to a CDR of 0.5 and two remained stable at CDR 1. Of the 14 participants with questionable or very mild dementia (CDR 0.5), four improved to definite cognitive normal status (CDR 0), seven remained stable at CDR 0.5 and three declined. Of the persons who declined two had adverse life events that contributed to their decline. Of the eight persons with definite dementia (CDR 1 or 2), 5 (62.5%) showed clinical improvement and 7 (87.5%) remained stable or improved. Using a random prediction model based upon the observed decline rate, the observed improvement was statistically significant (p=1.8e-02). No relationship between baseline DHA-plasmalogen levels and clinical response was observed. Of the nine responders, five were in the low (Q1,Q2) group and four were in the high (Q3,Q4) group.
The 30 second sit stand test is a common test used to evaluate core muscle strength and is strongly correlated with sarcopenia or muscle wasting. The test simply counts how many times a person can stand up and sit down in a 30 second period. A change from baseline of either +1 or -1 or 0 was considered stable. An increase of 2 or more was considered an improvement and a decrease of 2 or more was considered a decline. Three of the four participants with moderate dementia exhibited significant improvements in mobility (4 or 5 additional sit-stands) and one had a decline of 2 sit-stands. Of the participants with mild dementia, two exhibited improvement, one no change, and one declined. Of the 13 participants (one participant was unable to perform the test) with questionable or very mild dementia (CDR 0.5), 7 exhibited significant improvement, 4 were stable, and two declined. Using a random prediction model based upon the observed decline rate, the observed improvement was statistically significant (p=2.9e-05).
ProdromeNeuro was well tolerated at all dosages and no adverse reactions were observed or reported.
Dr. Goodenowe explains the trial design and clinical outcomes in C105 – ProdromeNeuro improves cognition and mobility in cognitively impaired persons.