Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2000-02-04
2001-02-06
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
Reexamination Certificate
active
06184251
ABSTRACT:
FIELD OF INVENTION
This invention relates to fatty acids and their use.
GENERAL
Dyspraxia or apraxia, is a problem of human development, giving difficulty in planning and carrying out skilled non-habitual motor acts in the correct sequence (Fisher, Murray & Bundy, 1991). It is an impairment or immaturity of the organisation of movement, associated with which there may be problems of language, perception and thought. (Dyspraxia Trust 1995). Several different terms have been used to describe this disorder, Developmental Dyspraxia, Clumsy Child Syndrome, Minimal Brain Dysfunction, Perceptual Motor Dysfunction, Sensory Integrative Dysfunction, Motor Learning Difficulty. Apraxia, and Development Co-ordination Disorder. The term used in the Diagnostic and Statistical Manual of Mental Disorders DSM IV Washington, D.C. (American Psychiatric Association 1994) is Developmental Co-ordination Disorder., The World Health Organisation International Classification of Diseases Code (ICD-9-CM) is 315.4.
Dyspraxia is now recognised to be caused by an immaturity of brain development associated with poor synaptic transmission and possibly poor arborisation of neurones, that is to say a disorder with an organic basis.
In practical terms dyspraxics are poorly coordinated, disorganised, have problems of ideation. motor planning and execution so that written work and ball games are extremely difficult for them. Handwriting is poor. Poor memory, restlessness and impulsiveness may be features of the condition. Poor peer relations as a consequence of their clumsiness and slow learning of games lead to low self esteem.
FATTY ACIDS GENERALLY
The n-6 and n-3 essential fatty acids are related as below.
TABLE 1
n-6 EFAs
n-3 EFAs
18:2n-6
18:3n-3
Linoleic acid (LA)
&agr;:-linolenic acid (ALA)
↓
&dgr;-6-desaturase
↓
18:3n-6
18:4n-3
&ggr;-Linolenic acid (GLA)
Stearidonic acid
↓
elongation
↓
20:3n-6
20:4n-3
Dihomo-&ggr;-linolenic acid
Eicosatetraenoic acid
(DGLA)
↓
&dgr;-5-desaturase
↓
20:4n-6
20: 5n-3
Arachidonic acid (AA)
Eicosapentaenoic acid (EPA)
↓
elongation
↓
22:4n-6
22:5n-3
Adrenic acid
↓
&dgr;-4-desaturase
↓
22:5n-6
22:6n-3
Docosahexaenoic acid (DHA)
The acids, which in nature are of the all-cis configuration, are systematically named as derivatives of the corresponding octadecanoic, eicosanoic or docosanoic acids, e.g. z,z octadeca-9,12-dienoic acid or z,z,z,z,z,z docosa-4,7,10,13,16,19 hexaenoic acid, but numerical designations based on the number of carbon atoms, the number of centres of unsaturation and the number of carbon atoms from the end of the chain to where the unsaturation begins, such as. correspondingly, 18:2n-6 or 22:6n-3 are convenient. Initials, e.g. EPA and shortened forms of the names e.g. eicosapentaenoic acid, are used as trivial names in some of the cases.
PRESENT WORK
The invention is discussed in general terms later herein but broadly we have found dyspraxia to be due to inadequate supplies of the long chain polyunsaturated fatty acids docosahexaenoic acid (DHA) and arachidonic acid (AA). Dyspraxia may thus be treated by providing DHA and AA, the earlier the better. LA and especially GLA and DGLA are metabolic precursors of AA, and may be used in its stead. Likewise ALA and especially SA and EPA are precursors of DHA and may be used in its stead. Antioxidants may optionally be provided as well since they protect the highly polyunsaturated fatty acids and increase their incorporation into cell membranes.
DHA and AA are major constituents of the retina, of nerve tissue and of the brain. DRA is found in high concentrations at synapses and AA is important for cell signalling. Recent work has shown that their provision to children is important in the normal development of visual acuity, dark adaptation and cognitive function and is of particular benefit for dyslexics. However to our knowledge no one has previously suggested that dyspraxic individuals might also benefit from this treatment approach.
We first found a dramatic response to treatment with AA, DHA and GLA in a boy with dyspraxia. The subject was a 5 year old boy with severe dyspraxia. He exhibited all the classic signs of dyspraxia, he was clumsy, had poor balance and consequently bumped into objects and was accident prone. His drinks were always provided in a cup with a lid and a straw because of spillage. He did not enjoy and avoided drawing or learning to write because of poor fine motor skills and the difficulty of holding a pencil and physically drawing the lines as he wished. He had similar difficulty with scissors and cutting out. Clumsiness in ball games and difficulty with catching and hitting a ball lead to poor self esteem and difficulties in playing with friends. Characteristically at school he avoided the tasks which involved reading and writing and was easily distracted in class.
After supplementation with essential fatty acids and antioxidant for two months, his fine and gross motor skills and balance had improved so much that he rarely tripped over, he could carry liquid in an uncovered cup, and could catch a ball and hit a ball with a baseball bat. All these skills were absent before supplementation.
His language skills had also improved with more desire to read, fewer errors and faster reading. The social disruption in school caused by clumsiness and impulsiveness had also lessened. His teacher, unaware of the supplementation, reported that he was working well and was less disruptive. Overall the boy was calmer, happier and more willing to do things.
Following this success members of a local group affiliated to the Dyspraxia Foundation invited the applicants to test their children before and after supplementation with a mixture of n-3 and n-6 fatty acids. Seventeen families volunteered for this study. Informed consent was sought from the parents and children. All children completed the baseline assessment but two failed to attend for the final assessment. There were eleven boys and four girls with age range 5-12 years. Fine and gross motor skills were assessed using the ABC Movement Assessment Battery for Children (Henderson & Sugden 1992). The test consists of two parts, a check list, completed by an adult familiar with the child, and a series of objective measures of motor skills to assess manual dexterity, ball skills and static and dynamic balance. The check list examines the complex interactions between the child and the physical environment. It can be used on a one off basis to screen for children with problems or as in this study to evaluate intervention. The movement tests are also designed to be used to evaluate intervention. The test battery was completed at the outset and after 4 months supplementation with tuna oil, evening primrose oil, thyme oil and vitamin E. The supplement provided 480 mg DHA, 35 mg arachidonic acid, 96 mg gamma linolenic acid, 80 mg vitamin E and 24 mg of thyme oil daily.
There are other similar test batteries for movement assessment but this series was chosen because it is well established in use in several European countries and the USA and has been tested for reliability, validity, age and gender effects effects. It is used across the board to assess movement skills. The check list component can be used to screen children with movement problems. Children who fall on or below the 15
th
percentile represent a marked degree of movement difficulty. Such children require further monitoring and assessment and may need immediate intervention. Children who fall on or below the 5
th
percentile required detailed assessment and special consideration in terms of management and remediation programmes.
The objective measures of manual dexterity, ball skills and static and dynamic balance are summed to derive the Total Impairment Score (TIS). Percentile norms for TIS are used to assess severity of impairment, The cut off points are similar to those for the check list, 5
th
and 15
th
percentiles. If children fall on or below these percentiles intervention and remediation programs are required.
At the outset all children had checklis
Horrobin David F.
Stordy Barbara Jacqueline
Jarvis William R. A.
Nixon & Vanderhye
Scotia Holdings PLC
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