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Evidence of an association of LRRK2 polymorphic variants with PD was reported in 2005 when a haplotype that increases disease risk when present in two copies was identified among sporadic

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LRRK2 in Parkinson’s disease: genetic and clinical

studies from patients

Udhaya Kumari1,2and E K Tan1,2

1 Department of Neurology, Singapore General Hospital, Singapore, Singapore

2 National Neuroscience Institute, Duke-NUS Graduate Medical School, Singapore, Singapore

Introduction

Parkinson’s disease (PD), a chronic progressive

neuro-degenerative movement disorder, is characterized

clini-cally by resting tremor, rigidity, bradykinesia and

postural instability This condition was first described

in 1817 by James Parkinson in his seminal paper ‘the shaking palsy’ Although PD predominantly affects older individuals,  10% of people with the disease are under the age of 40 years [1] The

neuropathologi-Keywords

LRRK2; mutations; Parkinson’s disease;

penetrance; polymorphisms

Correspondence

E.-K Tan, Department of Neurology,

Singapore General Hospital, Outram Road,

Singapore 169608, Singapore

Fax: +65 6220 3321

Tel: +65 6326 5003

E-mail: gnrtek@sgh.com.sg

(Received 30 May 2009, revised 27 July

2009, accepted 6 August 2009)

doi:10.1111/j.1742-4658.2009.07344.x

Mutations in leucine-rich repeat kinase 2 (LRRK2) (PARK8) are associ-ated with both familial and sporadic forms of Parkinson’s disease Most studies have shown that LRRK2 mutations may explain between 5% and 13% of familial and 1–5% of sporadic Parkinson’s disease Importantly,

a common recurrent mutation (G2019S) located in the kinase domain has been reported across most ethnic populations, with the highest prevalence among Ashkenazi Jews and North African Arabs A recent worldwide meta-analysis pooling data from 24 populations reported a higher occur-rence of G2019S in southern than in northern European countries and the penetrance is estimated to be  75% at the age of 79 years The R1441 ‘hotspot’ amino acid codon residue (G⁄ H ⁄ C) in the Ras of com-plex proteins domain is the second most common site of pathogenic LRRK2 substitutions after G2019S, with most carriers developing symp-toms by the age of 75 years Two polymorphic variants found almost exclusively among Asians (G2385R and R1628P) have been shown to increase the Parkinson’s disease risk by approximately two-fold The mutational event associated with R1628P is more recent, occurring

 2500 years ago, compared to estimates of 4000 years for G2385R carri-ers LRRK2 mutation carriers generally simulate late onset Parkinson’s disease and present with the usual typical clinical features Genetic testing for G2019S in sporadic late-onset Parkinson’s disease can be considered

in some situations and may be useful in populations with high carrier sta-tus The identification of asymptomatic mutation and risk variant carriers provides a unique opportunity for recruiting these subjects in potential neuroprotective trials and longitudinal studies to identify biomarkers of neurodegeneration

Abbreviations

ANK, ankryn; ARM, armadillo; COR, C-terminal of ROC; LRRK2, leucine-rich repeat kinase 2; PD, Parkinson’s disease; PET, positron emission tomography; ROC, Ras of complex proteins.

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cal hallmarks are characterized by a progressive and

profound loss of neuromelanin-containing

dopaminer-gic neurons in the substantia nigra pars compacta with

the presence of eosinophillic, intracytoplasmic and

pro-teinaceous inclusions termed as Lewy bodies and

dys-trophic Lewy neurites in surviving neurons [2] For

many decades, the relative influence of genes and

envi-ronmental agents on the pathophysiology of PD has

been debated However, subsequent to the discovery of

a-synuclein as a causative gene in 1997, there is

increas-ing recognition that genes play an important role in

the disease, particularly in familial cases At present,

many causative genes and susceptibility loci have been

identified (Table 1) Many of these PD-associated

genes affect both familial and sporadic forms and are

found in a number of different ethnic populations The

discovery and subsequent identification of the gene for

leucine-rich repeat kinase 2 (LRRK2) (PARK8) as a

causative PD gene has significantly contributed to our

understanding of not only the eitopathology of the

condition, but also provides information that could

potentially influence clinical management

LRRK2 is a large (280 kDa) multidomain protein,

with pathogenic mutations distributed throughout its

length, although there is a degree of clustering within

the enzymatic domains The gene encompasses 144 kb,

with an ORF consisting of 7581 bp (in 51 exons) and its encoded protein is unusually large (2527 amino acids) It is a multidomain protein comprising (from N-terminal to C-terminal), armadillo (ARM), ankryn (ANK), LRR, Ras of complex proteins (ROC), C-ter-minal of ROC (COR), mitogen-activated protein kinase kinase kinase and WD40 domains The presence

of the four protein–protein interaction domains (ARM, ANK, LRR and WD40) strongly suggests a role of LRRK2 in protein complex formation

Discovery of LRRK2 as a cause of PD

In 2002, Funayama et al [3] identified a novel locus

on chromosome 12p11.2–q13.1 that co-segregates with autosomal dominant parkinsonism in a family from Sagamihara (a region in Japan) consisting of 31 indi-viduals from four generations Two large families with autosomal-dominant late-onset parkinsonism, family A (German–Canadian) and family D (Western Nebraska) are also linked to this PARK8 locus In 2004, missense LRRK2 mutations were identified in family A (Y1699C) and in family D (R1441C) Sixteen individu-als (eight unaffected and eight affected) in family A were genotyped and all affected were heterozygous for the mutation and all the unaffected aged over 60 years

Table 1 Genes and loci linked with PD.

No causative gene identified

Reported in a PD sibling pair

Pathogenicity uncertain

No causative gene identified

Pathogenicity uncertain

Awaiting more data

Awaiting more data

AD, Autosomal dominant; AR, autosomal recessive; UCHL1, ubiquitin carboxy-terminal hydrolase L1; PINK1, PTEN-induced kinase 1; ATP13A2, ATPase type 13A2; GIGYF2, GRB10-interacting GYF protein 2; HTRA2, HtrA serine peptidase 2; PLA2G6, group VI phospholipase A2; FBX07, F-box protein 7.

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did not have the mutation In family D, 34 individuals

were genotyped (ten affected and 24 unaffected) All

affected were heterozygous for R1441C mutation and

24 clinically unaffected were genotyped; only two older

than 60 years of age were mutation carriers These

individuals are considered to be at risk [4] At the same

time, another study revealed missense mutations

segre-gates with PARK8-linked PD in five families from

England and Spain The authors named the protein

dardarin because dardar is derived from the Basque

(i.e where families of LRRK2 are found) word for

tremor, and it was a common symptom [5]

Identification of a common LRRK2

mutation (G2019S)

In 2005, three concurrent reports identified a LRRK2

mutation (G2019S, which produces a glycine to serine

amino acid substitution at codon 2019) to be common

in both familial and sporadic PD [6–8] Nichols et al

[6] analyzed 767 affected individuals from 358

multi-plex families and revealed that 5% were either

hetero-zygotes or homohetero-zygotes for the mutation Di Fonzo

et al [7] found 6.6% of unrelated families from Italy,

Portugal and Brazil with PD and with autosomal

dom-inant inheritance harbor the mutation Gilks et al [8]

analyzed 482 sporadic PD patients and reported 1.6%

of them as having the mutation These three reports

highlighted, for the first time, that a common recurrent

mutation can be a cause of both sporadic and familial

PD and consequently set the stage for numerous genetic

screening studies for this mutation worldwide [9]

Prevalence of LRRK2 G2019S mutation

Most studies have shown that LRRK2 mutations may

explain between 5% and 13% of familial and 1–5% of

sporadic PD [4–9] (Fig 1) The variability depends on the ethnic population and the extent of genetic screening

Of greater interest is the prevalence of G2019S, which has been found to be very rare in Asia, South Africa and in some European countries, such as Poland, Greece and Germany However, that appears as a predilection for some ethnic races This mutation accounts for 13.3% of sporadic and 29.7% of familial PD among Ashkenazi Jews and 40.8% of sporadic and 37.0% of familial PD in North African Arabs [10,11] The muta-tion accounts for  1–7% of familial patients from European and US origin and for 1–3% of sporadic

PD from most Caucasian populations This mutation

is located in the kinase domain of the protein and may

be associated with increased kinase activity [12,13] The estimation of the penetrance of autosomal domi-nant mutations is a challenging task but it is essential for genetic counseling Penetrance estimates are usually high when they are based on high-risk families and might not apply to the general population The pene-trance of G2019S-associated disease increased from 17% at age 50 years to 85% at age 70 years in an initial family-based study, but varied in subsequent reports, depending on sample size, study design, inclu-sion of probands in the analysis and methods of calcu-lation To address some of these issues, Healy et al [14], in a recent worldwide meta-analysis, pooled data from 24 populations, involving 1045 individuals with LRRK2 mutations from 133 families Interestingly, they found a higher occurrence of G2019S in southern than in northern European countries The authors esti-mated the penetrance to be 28%, 51% and 74% at 59,

69 and 79 years of age, respectively The over-riding message is that, although the penetrance clearly increases with age, it is not complete because some very elderly carriers remain free of disease Ethnic dif-ferences for LRRK2 mutations have been reported

Fig 1 Genomic and protein structures of

LRRK2 LRRK2 has 2527 amino acids and

contains ARM, ANK, LRR, ROC, COR,

MAP-KKK and WD40 domains Proven pathogenic

mutations are shown in red Potentially

pathogenic mutations, for which

co-segrega-tion analyses were reported, are highlighted

in blue Variants of unknown significance,

found in single PD patients, are highlighted

in black Risk factors are shown in red and

in a yellow box.

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among Asian races For example, the LRRK2 G2019S

substitution has not been found in three independent

Chinese populations involving more than 2000 study

subjects, whereas it has been detected among Japanese

and rarely among Indians [15–17] Different founder

haplotypes have been described in G2019S carriers A

common 193 kb genomic region, so-called haplotype 1,

is shared by 95% of G2019S carriers of European,

North and South African and Ashkenazi Jewish origin

[18,19] The mutation possibly arose in Ashkenazi Jews

much earlier than in North African Arabs and

Euro-peans several thousand years ago [20] The frequency

of this haplotype in non-G2019S Chinese carriers in

both PD and controls is  30–33%, which is similar

to the frequency in European noncarriers [21] The

sec-ond rare haplotype is found in a total of five families

of European ancestry The third, found primarily in

Japanese carriers, has also been reported in a Turkish

family [22,23] Distinct G2019S haplotypes in different

races suggest that the mutation originates from

different founders in Europe and Asia

Mutational hotspot at position R1441

The R1441 ‘hotspot’ amino acid codon residues

gly-cine⁄ histidine ⁄ cysteine (G ⁄ H ⁄ C) in the ROC domain is

the second most common site of pathogenic LRRK2

substitutions, after G2019S [24] The R1441C mutation

was initially found in two autosomal-dominant PD

families [4] Affected individuals reported typical PD

symptoms and the mean age at onset in the first family

was 65 years Two asymptomatic mutation carriers

were more than 60 years old The phenotype of

carri-ers in the second family was similar, with mean age at

onset of 56 years Interestingly, Zabetian et al [25]

reported a R1441C patient with sporadic PD with

onset at age 61 years and all nine siblings were

asymp-tomatic even though they were more than 60 years

old These initial observations suggest that the

pene-trance of R1441C can be highly variable Recently,

in a worldwide pooled analysis involving 33 affected

and 15 unaffected R1441C mutation carriers, the

demographics and clinical features of LRRK2 carriers

were found to be generally similar to idiopathic PD

[14] More than 90% had developed symptoms by

75 years of age Four independent founders for the

R1441C mutation have also been reported [26] The

apparent high penetrance in this pooled analysis

needs to be interpretated with caution because this

is not a population-based study Although R1441C

is found in different ethnic races, R1441G is most

common in the Basque Country ( 20%) and is rare

outside of Northern Spain [27–29] A common

founder for R1441G carriers was found to date back

to the 7th Century in Northern Spain [29] R1441H has been described in four probands of diverse ethni-cities [30]

Polymorphic variants G2385R variant

The discovery of polymorphic risk variants is unex-pected because few of genetic variants linked to PD have been consistently replicated [31] Evidence of an association of LRRK2 polymorphic variants with PD was reported in 2005 when a haplotype that increases disease risk when present in two copies was identified among sporadic Chinese PD population in Singapore [32] However, other studies did not reveal association with any LRRK2 haplotypes in Caucasians, suggesting the existence of ethnic-specific differences [33–35] In

2005, Mata et al [24,36] reported a G2835R variant a

PD family from Taiwan and it was thought that it could be a pathogenic mutation However, Tan et al [37] and Di Fonzo et al [38] subsequently found that the G2385R variant is a common polymorphism and increases the risk of PD in Singaporean and Taiwan populations This association has been consistently replicated among Chinese and Japanese populations with an average carrier rate of 9% in PD and 4% in controls [37,39–41] The population attributable risk for the heterozygous genotype is 4% It has been sug-gested that the G2385R variant possibly originates from one common ancestor in China 4000 years ago [40] Thus far, LRRK2 G2385R appears absent in Caucasian subjects [41] Interestingly, the G2385R var-iant has not been shown to be a risk factor for PD among Indians and Malays in Singapore or to be asso-ciated with other neurodegenerative conditions such as Alzheimer’s disease [42] The LRRK2 G2385R is located in the WD40 domain, and the base substitu-tion alters the net positive charge of the WD40 domain Because WD40 domain is involved in mediat-ing protein–protein interactions, the LRRK2 G2385R variant may impact on interactions with substrates and⁄ or regulatory proteins Preliminary studies suggest that it may lead to decreased kinase activity and be pro-apoptoptic under cellular stresses [12,41] The clin-ical features of G2385R carriers are similar to noncar-riers, although those individuals with familial PD appear to have a higher carrier rate [43] Recently, a large-scale pooled analysis involving multiple Asian centers revealed that the G2385R variant lowers the age of onset of PD [44] However, because almost all the G2385R carriers are heterozygotes, the additive

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effect of carrying two copies of the variant could not

be meaningfully determined

R1628P variant

R1628P is the second risk factor to be identified in the

Han Chinese population after the G2385R because

investigators found that it increased the risk of PD

among Chinese in Taiwan and Singapore [45,46]

LRRK2 R1628P is located in the COR domain and is

evolutionarily conserved across species, highlighting

the importance of the residue (arginine) to protein

function The LRRK2 R1628P variant has not been

detected in Indian subjects and does not appear to be

associated with risk among individuals of Malay

eth-nicity [47] It is possibly rare or absent among whites

and, interestingly, has not been detected in Japanese

patients The phenotype of carriers appears similar to

idiopathic PD [45,48] It would appear that the

muta-tional event associated with LRRK2 R1628P is more

recent, occurring  2500 years ago, compared to

estimates of 4000 years for carriers of the LRRK2

G2385R variant [46] Very few subjects carry both

G2385R and R1628P risk alleles However, the

esti-mated population attributable risk of R1628P and

G2385R variants is 10% [48] The functional

activi-ties of R1628P have yet to be determined

Phenotype–genotype correlation

On the basis of findings of a multicenter pooled

analy-sis, it is quite clear that R1441C, G2019S and other

mutational carriers share a common phenotype with

idiopathic PD [14,26] Thus, LRRK2 carriers simulate

late onset PD and present with the usual typical PD

clinical features These observations challenge the

clas-sification of ‘idiopathic PD’ Although long-term

longi-tudinal data are not available, Healy et al [14], in

their worldwide pooled analysis, reported that both

motor symptoms and nonmotor symptoms (e.g

cogni-tion) of LRRK2 carriers appear to be milder than

those of idiopathic PD

Phenotype studies

Positron emission tomography (PET), by providing

quantitative information on dopaminergic function, is

useful for the in vivo investigation of PD [18

F]6-fluoro-l-dopa uptake correlates with the number of nigral

dopamine neurons in humans and in animal models of

PD [49] Thus, PET and other functional imaging

modalities provide a useful means to monitor nigral

integrity in LRRK2 asymptomatic and symptomatic

carriers In one of the earliest functional imaging stud-ies on LRRK2 carriers, Adams et al [50] reported that abnormalities on functional imaging studies are quite similar between LRRK2 carriers and sporadic PD More recently, a multitracer PET study was carried out in asymptomatic members of the kindred from family D (R1441C) with some of them rescanned 2–3 years apart [49] Worsening of PET markers over time was greater compared to healthy controls for some of the carriers This suggests that progressive dopaminergic dysfunction occurs in pre-symptomatic members of the LRRK2 kindred The identification of these individuals could provide an opportunity for potential early neuroprotective interventions

Interestingly, transcranial sonography studies in LRRK2 carriers revealed that substantia nigra echoge-nicity was greater compared to controls but smaller than in idiopathic PD [51] However, it remains specu-lative as to whether iron has a different pathophysio-logical role in LRRK2 carriers than in idiopathic PD Hyposmia is a common finding in majority of PD patients Using the University of Pennsylvania Smell Test, one study showed that the mean test score in G2019S parkinsonian carriers was lower than that in healthy controls, but no different in patients with PD [52] Two asymptomatic G2019S carriers had a normal smell test This test cannot differentiate LRRK2 carriers from idiopathic PD Myocardial 123 I-metaiod-obenzylguanidine (which assesses postganglionic sym-pathetic cardiac innervation) uptake is decreased in most PD patients Quattrone et al [53] showed that 50% of G2019S carriers compared to all the patients with idiopathic PD had impaired 123 I-metaiodobenzyl-guanidine uptake This suggests that G2019S carriers may not be a homogenous entity Taken together, the current limited clinical studies of LRRK2 mutation carriers appear to suggest that, although clinically inseparable, there may be subtle differences between these carriers with respect to idiopathic PD and further investigations should be considered It is unclear how the variable pathology associated with G2019S muta-tions influences the phenotypic features

Genetic testing for G2019S

A genetic test can help confirm or exclude a suspected genetic disease The test can also help determine the risk of developing the disorder for an individual The recent discovery of the common LRRK2 G2019S mutation provides an opportunity for testing in fami-lies with autosomal-dominant pattern inheritance, as well as in some cases of sporadic PD However, the clinical utility of such testing would require careful

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evaluation of the potential risks and benefits of testing

and the availability of treatment options to manage

those at risk However, the feasibility of diagnostic

and predictive testing of PD is not as simple as it

appears to be Many questions have been raised,

including the sensitivity and specificity of the test and

reliability of the laboratory carrying the test [54]

Spe-cific to G2019S testing, its incomplete penetrance

com-plicates pre-symptomatic genetic testing For other

LRRK2 mutations, there are questions regarding its

actual pathogenicity Some investigators have argued

that such testing should be carried out under a

research setting rather than as part of a clinical service

because it will help remove concerns regarding

insur-ability and other social issues Genetic testing should

preferably be supported by a multidisciplinary team

with expertise in handling pre-testing and post-testing

related problems A recent study has demonstrated

that the relationship between the level of genetic

knowledge and the attitude towards the potential risks

and benefits of predictive genetic testing in PD may be

influenced by racial and cultural differences and, thus,

this has to be taken into consideration in counseling

programs [55]

For LRRK2 testing, there is a lack of available

sci-entific information with respect to advising subjects on

their prognosis and the result will not alter the

man-agement of the disease The large size of the LRRK2

makes it impractical to provide comprehensive

screen-ing Furthermore, the pathogenicity of many of the

putative heterozygous LRRK2 mutations is unclear

because many of them have been described in single

patients and no segregation data in affected families

are available Nevertheless, testing for G2019S in

spo-radic late-onset PD can be considered in some

situa-tions and may be useful in populasitua-tions with high

carrier status [56] It will be useful if professional

bodies come together to set up guidelines and help

provide advice to both patients and the public

Future directions

The discovery of the gene for LRRK2 as a causative

gene in PD is both extremely important and exciting

because LRRK2 mutations are the most common

cause of familial PD and a common mutation and two

common polymorphic risk variants have been

identi-fied Furthermore, the varied prevalence of causative

mutations and risk variants across different ethnic

populations suggest that, besides a common founder

effect, epigenetic or other factors such as

environmen-tal or lifestyle factors may be important Multicenter

studies to determine the prevalence, penetrance and

phenotype–genotype correlation for the various reported LRRK2 mutations, and gene–environmental interaction would be needed As the the gene for LRRK2 is large, studies that report direct sequence analysis of the entire gene and copy number analysis are still limited Thus, familial segregation analysis and functional studies to determine which ones are truly pathogenic are needed Additional studies to determine haplotype structure, population and ethnic differences and identification of new risk variants will also be use-ful The identification of asymptomatic mutation and risk variant carriers provides a unique opportunity in the field because these subjects are ideal candidates for potential neuroprotective trials and longitudinal studies

to identify biomarkers of neurodegeneration Clinical, genetic and biological information gathered from genetic underpinnings of PD will hopefully be trans-lated into better treatment for patients

Acknowledgement Supported by Singapore Millennium Foundation, National Medical Research Council, Biomedical Research Council, Duke-NUS Graduate Medical School and SingHealth Services

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