ClinActis Webinar: Tackling Dementia & Alzheimer's in Asia Pacific

Tackling Dementia &
Alzheimer’s in Asia Pacific
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 - Telephone: +65 6436 5500 - info@clinactis.com

Christophe Tournerie, MD – Owner and CEO
Dr. Tournerie has more than 20 years experience in clinical research in
Europe and Asia Pacific including Japan, working with biotechnology
companies, pharmaceutical companies and clinical research organizations.
After completion of his medical studies in Paris and various hospital
assignments in France, Dr. Tournerie spent a period of 3 years at the
National Medical Research Institute in France in the field of drug
development in anti-HIV products. His introduction to the pharmaceutical
industry was as Medical Director in an American biotechnology company
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
About the Presenter: Christophe Tournerie, MD, Founder and CEO
developing anti-HIV products. Then, he moved to a large global CRO, heading the Project
management Department for South Europe, and then as Head of Operations in the Japan
affiliate.
Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national
Pharmaceutical Company, based in Singapore.
More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO, based in
Singapore. During this assignment, Dr. Tournerie developed the business strategy for the
region, successfully established and directed operations in 12 countries and built a highly
professional team.

Paul Lim – Director, Clinical Research
Paul Lim has 15 years clinical research experience with global
pharmaceutical companies and global CROs. He holds a Master’s
Degree in Pharmacy (Clinical Pharmacy) and started his clinical
research career as a Clinical Pharmacist in the National University
Hospital in Malaysia.
He later joined an international CRO as senior CRA in Singapore, and
another CRO as Clinical Operations Manager. Subsequently, he joined a
Biotech company as Regional Clinical Research & Development
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
About the Presenter: Paul Lim - Director, Clinical Research
Manager Asia, Australia, Europe, US, Europe, and Middle-East regions. After this
experience, he joined an international pharmaceutical company as Senior Clinical
Development Manager Clinical Development, Greater China and Asia.
Lastly, before joining ClinActis, he held the position of Senior Clinical Site Manager Asia in
another leading international pharmaceutical company.
His therapeutic areas experience includes cardiovascular, oncology, endocrinology, infectious
diseases, neurology, and respiratory diseases. Paul brings with him a wide breadth of
project management and clinical research experience.

Agenda

§  Dementia and Alzheimer’s Disease Statistics in
Asia Pacific
§  Focus on Key Countries
§  Considerations for CNS Clinical Trials in Asia
Pacific
§  Benefits of Conducting AD Clinical Trials in Asia
Pacific
§  ClinActis CNS Experience

Dementia and Alzheimer’s Disease Statistics in Asia Pacific

§  Population of the Asia Pacific region in 2015 estimated from
United Nations data at 4.4 billion. Population aged 60 years
and above estimated at 12% in 2015.
§  The dementias are a group of diseases characterised by loss
of short-term memory, other thinking (cognitive) abilities
and daily functioning.
§  Alzheimer’s disease and vascular dementia the most
common types of dementia.
§  Population with dementia in Asia Pacific forecasted to
increase from 13.7 million people in 2005 to 64.6 million by
2050.

Prevalence and Incidence in Asia Pacific

‘000 People
Prevalence
2005
Incidence Prevalence
2020
Incidence Prevalence
2050
Incidence
Australia 195.4 60.2 301.3 91.1 664.1 199.7
China (inc Macao) 5,541.2 1,721.0 9,596.3 2,916.7 27,004.4 8,269.0
HongKong SAR 59.7 18.5 109.2 32.6 332.0 99.6
India 3,248.5 1,026.8 5,541.8 1,714.4 16,290.1 4,974.6
Indonesia 606.1 191.4 1,016.8 314.1 3,042.0 932.0
Japan 1,871.2 570.2 3,251.3 983.4 4,873.1 1,417.7
Malaysia 63.0 20.1 126.8 39.0 453.9 138.8
NewZealand 38.2 11.8 54.6 16.6 117.6 35.5
Pakistan 330.1 107.3 566.6 179.3 1,916.2 584.3
Philippines 169.8 54.8 316.3 99.2 1,158.9 353.9
Singapore 22.0 6.8 52.6 15.7 186.9 56.7
South Korea 246.3 75.5 542.2 164.3 1,569.9 475.4
Taiwan 138.0 43.1 253.4 76.6 659.3 199.4
Thailand 229.1 71.4 450.2 137.2 1,233.2 377.0
Total Region 13,703.6 4,282.1 23,727.1 7,262.3 64,641.5 19,687.3

Australia

§  413,106 Australians living with dementia
§  55% Female and 45% Male
§  By 2025 people with dementia expected to increase to 536,164
§  Without a medical breakthrough, number of people with dementia expected to
reach 1,100,890 by 2056
§  Currently around 244 people each day are joining the population with
dementia. New cases of dementia will increase to 318 people per day by 2025
and over 650 people per day by 2056
§  Estimated 25,938 people with younger onset dementia, expected to rise to
29,375 by 2025 and 42,252 by 2056
§  Dementia services delivered within the well-established institutional and
professional context of the health care system, and the closely related aged
care system.
§  State and territory governments also responsible for the funding and delivery
of public health services through hospitals and a range of community settings.
Private sector involvement in primary care and the delivery of community
services also adds to the complexity.

Korea

§  Up to 10% of the elderly in Korea suffer from dementia. Prevalence
estimates of Alzheimer's disease range from 4.2% to 9.0%. Annual
incidence rates for Alzheimer's are 2.7% to 3.4%. Thus major mental
disorders are already prevalent among the Korean elderly and are likely to
increase rapidly.
§  Healthcare system well organized to take care of Alzheimer’s patients with
Primary Care: Private Clinic, Public Health Centers, General Hospital
§  Standard therapy in Korea includes the following medication, which should be
taken by patients within 2 years after diagnosis:
§  Antioxidant, NSAID, Hormone Therapy e.g. estrogen, NMDA antagonist +
ChEI or memantine
§  For Mild – plus cognitive disorder Tacrine or Donepezil (Aricept Tab) is
given to the patient.
§  For Mild to Moderate: Tacrine, Donepezil, Rivastigmine (Patch or Oral),
Galantamine
§  BPSD’s sign: antidepressants, antipsychotic drug, Mood Stabilizer is given
to the patient.

Korea (Continued)

§  Standard therapy should also include a change of lifestyle and
environment, cognitive activities & training, and behavior training.
§  Patients also provided with a health caregiver or may use
hospitalized facilities.
§  In general, most potential patients visit private clinics. If they are
suspected to be diagnosed with dementia, the clinic’s doctor refers
patients to either general hospitals (3rd healthcare hospital defined by
government medical law) or middle hospitals (2nd healthcare hospital
defined by government).

Taiwan

§  10.63% of population in Taiwan is older adults, and 4.8% of older
adults have dementia.
§  110,000 Taiwanese suffer from Alzheimer's disease and other
degenerative disorders, according to a survey released by the Taiwan
Alzheimer's Disease Association. Alzheimer's disease causes 60-70% of all
cases of dementia.
§  Healthcare system well organized to take care of Alzheimer’s patients, either
in hospitals, where patients are treated in outpatient and inpatient service
from neurobiology and psychiatry departments, or in nursing homes, or in
long-term care facilities.
§  Standard therapy available in Taiwan includes medications covered by health
insurance if the patient meets the criteria:
§  Acetylcholinesteraseinhibitor, AChEI: Aricept, donepezil, Exelon,rivastigmine,
Reminyl, galantamine
§  NMDA receptor antagonist: Ebixa, memantine, Witgen,memantine
§  Antipsychotics
§  Antidepressants
§  Cognitive therapy, reminiscence therapy, music therapy and art therapy.

Taiwan (Continued)

§  With 4 leading neurologists in the field of Alzheimer's disease in
Taipei, Taiwan, they have good patient population at their site and
they have experience in several clinical trials.
§  We can safely assume that there are other sites based outside Taipei
that can also be involved and offer a solid patient potential.

Singapore

§  Prevalence of dementia and cognitive disorders to increase rapidly over the
coming years. Fast ageing population with 15-20% of the total population
above the age of 65 by year 2030.
§  About 25,000 patients have dementia and this number is set to increase to
53,000 by 2020 and by 2050 the projected figure will further increase
to 187,000.
§  Ministry of Health provides clinical guidelines for Alzheimer's, and support
care funding through the Care Liaison service, a central body established to
coordinate and facilitate the placement of elderly sick to step-down services
(nursing homes & chronic sick facilities).
§  In later stages of Alzheimer’s disease, the patient may not be aware of the
consequences of the illness and it would then be a family decision to get him/
her assessed and investigated. Treatment would mostly be based on the
symptoms observed and arrangements have to be made for the long-term
care of the individual by way of providing for care-givers, especially if there
are none in the family.

Singapore (Continued)

§  In clinical guidelines, health authorities recommend two
groups of drugs: one (Cholinesterase inhibitors) to help
improve the ability to think, understand, and remember;
another group of drugs is also sometimes used in Alzheimer's
disease to help with behavioral problems associated with
Alzheimer's disease, such as aggressiveness, agitation,
depression, and anxiety.
§  5 Potential clinical sites in Singapore

Hong Kong

§  Population ageing rapidly, such that the population aged 60 and above more
than doubled during the past two decades, from 531,600 (10.3%) in 1981 to
1,351,000 (19.2%) in 2011.
§  In 2039, there will be nearly three million people aged 60 and above
§  Combining the community and institutional populations, the estimated
number of people aged 60 and above with dementia would increase from
103,433 in 2009 to 332,688 in 2039, an increase of 222%.
§  Only symptomatic treatments are available. Donepezil, rivastigmine and
galantamine are the currently approved cholinesterase inhibitors for the
treatment of mild, moderate, and severe Alzheimer's disease. Memantine is
another symptomatic treatment for moderate-to-severe Alzheimer's disease
patients.
§  Vitamin E has antioxidant properties, and may be used in some Alzheimer's
disease patients without vascular risk factors.
§  Concurrent non-pharmacological and psychosocial management of patients
and their caregivers also has a very important role.
§  4 Potential clinical sites in Hong Kong

Malaysia

§  50,000 people with Alzheimer’s disease. Most of them not
diagnosed because relatives think symptoms are a normal part of
growing old and do not seek medical advice.
§  Annual mortality rate per 100,000 people from Alzheimer’s Disease
and other dementias has increased by 46.4% since 1990, an average
of 2.0% a year.
§  There are no specially designated residential care or long-term care
nursing homes provided by the government for people living with
dementia aside from the geriatric wards in major government
hospitals and private hospitals.
§  Nursing homes and community care centers managed by the private
sector do provide care for people with dementia but the care staff are
not specifically trained to care for people living with dementia.

§  Clinical practice guidelines recommend drugs to be used
synergistically with psychosocial interventions to improve cognition,
function and behavior based on the grading of disease.
§  Cognitive enhancers include acetylcholinesterase inhibitors (AChEl)
and N-methyl-D-aspartate (NMDA) receptor antagonist are widely
used to enhance cognitive performance in AD patients.
§  Other agents or supplements including ginkgo, vitamin E, omega-3
fatty acid, folic acid, vitamin B and huperzine A are prescribed
commonly by the primary physician for AD patients.
§  AD can be treated in:
§  20 hospitals (private and government) with Geriatricians
§  18 hospitals (government) with Psychiatrists
§  18 hospitals (private and government) with Neurologists
Malaysia (Continued)

Countries to Consider for Clinical Trials in AD in Asia Pacific

§  Australia, Singapore, Taiwan, Korea, Hong Kong &
Malaysia.
§  Currently no proven cure for MCi and dementia,
hence patients and doctors are very willing to
participate in drug trials.

Study Start-Up Timelines

§  Singapore among the shortest timelines for obtaining regulatory approvals, between 7 – 9
weeks. Submission dossiers in English, with only the Informed Consent Form (ICF) requiring
translation. Well organized central ECs for the various hospital clusters, with predictable review
and approval timelines.
§  Korea and Taiwan almost similar regulatory timelines, between 13 and 15 weeks. Regulatory
submissions in these countries will require translations of study documents, including the study
protocol (or protocol summary) and ICF. Taiwan has a Joint IRB which can review clinical trial
applications for a significant number of the major hospitals in Taiwan.
COUNTRY EC RA OVERALL TIME PROCEDURE
Korea 3-9 weeks 8-10 weeks 15 weeks parallel
Australia 8-12 weeks
2-5 days
(CTN) 10-14 weeks Sequential
Taiwan 13 weeks 8 weeks 13 weeks parallel
Singapore 6 weeks 5 weeks 7 weeks parallel
Hong Kong 8-10 weeks 8-10 weeks 10-12 weeks Parallel
Malaysia 6-8 weeks 6 weeks 8 weeks Parallel

Country Challenge Challenge Challenge Challenge
Korea Full IMPD with
justifiable pre-clinical
and clinical data should
be available
Korean translated
documents required for
submission, including
Protocol, ICF, IB (partial)
etc.
Import license needed for
IMP and lab kits after
obtaining the protocol
approval from MFDS
(Generally, takes 7
business days).
If needle will be imported,
it can take longer time to
review.
If MFDS raise comment/
question, important to
prepare response in
timely manner to obtain
approval. MFDS able to
make comment not only
in the official letter but
also through phone.
(Official Letter includes
only brief request.
Details shared through
phone call)
Australia
All submissions to TGA
need to be done by local
sponsor with local entity
in Australia
Local sponsor name need
to appear in all the
essential study
documents, this includes
insurance, CTA, drug
label and ICF.
Regulatory Application: Points to Consider by Country

Taiwan Following documents
needed during
application of lab kits
import license:
•  Signed lab guarantee
letter to comply with
local regulatory
requirement
•  Lab kits should have
local market
authorization to sell
Some ICF formats need
to be adapted to local
requirements
Singapore
Lab kits import license
and Clinical Trial
Material application
needed after Clinical
trial Certificate (CTC)
application. Will take
some time for the
reviewer to approve the
application
Following information
commonly missed out &
resulted in HA submission
delays:
•  PI’s trial related
qualification in CV, list
of overseas trials
centers, PI’s NRIC
Number and PI’s email
address.
To remind PI to have
SINGPASS (Investigator’s
"Singapore Personal
Access”) ready in order to
login to HA System
(“PRISM”) for
acknowledgement of
submission

Hong Kong Obtaining PI’s
approval on HA
submission
documents in a
timely manner
contributes to
shorter preparation
timeline for
submission.
Import study drug sample for
HA submission- We inform
the PM about this
requirement as soon as
country confirmation.
Process is time-consuming
and might delay the HA
submission and approval
timeline.
Prior to samples being
imported - an advance
proforma invoice needs to
be provided to ClinActis to
arrange the logistics with
our CRA in Hong Kong
Some translation from
English to traditional
Chinese is required, e.g.
ICF, which usually takes
2-3 weeks
Hong Kong
(Continued)
We need to contact
DoH to follow up any
comments and/ or
DoH approval letter
(we may follow up
with DoH 3-5 days
after submitting IRB
approval letter)


Malaysia Mandatory to have
the source of IP
(porcine/bovine) to
be on the label. List
of requirements is in
the guidelines.
Face to face meeting with
regulatory officer to provide
brief explanation on protocol
design and checking on
completeness of dossier
during initial submission.
If dossier rejected by
regulatory officer, we will
need to re-arrange for a
second face to face
meeting with the officer to
discuss the revised dossier
until the completed
submission dossier is being
accepted by the authority
officer.
IRB approval required
for release of the
Clinical Trial Import
License (CTIL) of the
IMP.
Malaysia
(Continued)
Custom invoice and
original CTIL
required for custom
clearance purpose.
Lab Kit Import License
•  Quantity of lab kits to
be imported for each
site needs to be
applied to Medical
Device Authority
(MDA).
•  We will receive the
approval from MDA in
less than 1 month from
the date of application.
Lab Kit Import License
•  To expedite approval,
application can be done
before getting EC
approval.
•  MDA will only release
approval letter after
submission of the EC
approval for the site.
•  License valid for one
year

Site Capabilities in Asia Pacific

§  We can use highly skilled and experienced GCP/ICH qualified sites; PI and site
staffs currently taking part in our on-going Alzheimer study in the region. PIs
and team are well trained professionals for cognitive assessment. The teams
in our on-going studies have no issue to perform this assessment.
§  For raters, it is also important to consider standardized training – eg: online
training to ensure consistency in the assessments. Also, refresher trainings
(eg: every 6 months) help ensure raters remain updated on the trial.
§  If MRI/CT scans required, it is best to have centralized readers. Our sites are
familiar with online portal to upload scans for centralized reviewer.
§  Our local CRAs have developed relationships is key site personnel
§  We have experience working with the sites, allowing for fast study start up
due to knowledge of contracting and negotiating at each site
§  We use the Site CTA template rather than the sponsor’s or ClinActis’s
§  We start negotiation early and use a Site budget template
Site Contract Process

Logistics

§  Verify sites have adequate storage facilities (temperature,
space, security) for study products at PSVs, plan resupply
accordingly
§  Knowledge of local and national customs regulations
§  Logistics of dispensing of study products
§  MRI scans validation during PSV
§  Provide sites with study binder containing detailed instructions
for ordering of study product and materials, re-order forms,
contact persons at ClinActis and vendor
§  eDC system

Asia Pacific Process for Dementia Diagnosis

§  Patient will be referred by GP to specialist for further
evaluation of the condition.
§  This management is mainly applicable to developed countries
(Australia, Singapore, Korea, Taiwan, Hong Kong, Malaysia)
where:
§  People are more educated and can understand etiology of dementia and
would seek treatment from medical practitioner
§  People can afford the treatment in their own country with better
healthcare coverage
§  For developing countries, like Indonesia, Thailand, Philippines,
referral to GP might not be applicable because:
§  People will think this is part of the ageing process and ignore the
importance to seek treatment.

Benefits of Conducting AD Trials in Asia Pacific

§  Asia Pacific has good patient pools in the region, e.g.
Singapore pre-screened ~800 and Hong Kong pre-screened
~1,000 of patients with suspected mental disorder/
dysfunction in their clinic setting within 3-6 months.
§  Less costly than US/European countries.
§  GCP/ICH Trained and experienced site personnel and CRO
team.

CNS and AD Experience

Indication Study Title (Blinded)
Study
Phase
No. of
sites
No. of
patients
Location
Countries
Responsibilities
Client
(Blinded)
Alzheimer’s
Disease
A multicenter, double-blind, placebo-
controlled, randomised, parallel-group
phase 3 study to evaluate the safety and
efficacy of XXX in patients with mild to
moderate Alzheimer’s disease
III 25 202 KR, TW, SG,
MY, PH, HK,
TH
PM, Reg,
Monitoring
EU Pharma
Dementia A Double-Blind, Placebo-Controlled,
Randomized, Parallel Group, 12-Month
Safety and Efficacy Trial of XXX in
Subjects with Behavioral Variant
Frontotemporal Dementia
III 4 24 SG, AU Pre-study visit Asia Biotech
Progressive
Supranuclear
Palsy
A prospective, multicenter, randomised,
double-blind, placebo-controlled, parallel
groups, phase 2b/3 study to compare the
efficacy and safety of XXX versus placebo
in the treatment of patients suffering
from Progressive Supranuclear Palsy
(PSP)
III 20 30 SG, HK, KR,
TW, PH, MY,
TH
PM, Reg,
Monitoring
EU Pharma
Multiple Sclerosis A prospective, multicenter, randomised,
double-blind, placebo-controlled, parallel
groups, phase 2/3 study to compare the
efficacy and safety of XXX in combination
with riluzole versus placebo in
combination with riluzole in the treatment
of patients suffering from Amyotrophic
Lateral Sclerosis (ALS)
III 30 80 SG, HK, KR,
TW, PH, MY,
TH
PM, Reg,
Monitoring
EU Pharma

CNS and AD Experience (Continued)

Indication Study Title (Blinded)
Study
Phase
No. of
sites
No. of
patients
Location
Countries Responsibilities
Client
(Blinded)
Brain Injury A randomized, double-blind, placebo-
controlled trial to investigate safety
and
efficacy of XXX in patients with
traumatic brain injury.
III/ IV 12 216 AU, SG, HK,
PH
PM, Reg,
Monitoring
EU Pharma
Multiple
Sclerosis
Single-centre randomized
crossover open-label study of
pharmacokinetics,
pharmacodynamics and safety of
XXX and Rebif® (Merck Serono
S.p.А., Italy) after single
subcutaneous administration to
healthy volunteers
I 1 18 SG PM, Reg,
Monitoring
EU Biotech
Multiple
Sclerosis
Single-centre randomized
crossover open-label study of
pharmacokinetics,
pharmacodynamics and safety of
XXX and Avonex® (Biogen Idec.
Ltd., United Kingdom) after single
intramuscular administration to
healthy volunteers
I 1 18 SG PM, Reg,
Monitoring
EU Biotech

CNS and AD Experience with 72 GCP/ICH Clinical Sites

Indication
Total no.
of sites
No. of
sites in
SG
No. of
sites in
HK
No. of
sites in
TW
No. of
sites in
PH
No. of
sites in
MY
No. of
sites in
TH
No. of
sites in
KR
Alzheimer’s
disease 28 3 3 4 5 6 3 4
Dementia 4 2 0 0 0 0 0 2
Brain Injury 12 4 2 0 6 0 0 0
Progressive
Supranuclear
Palsy
15 0 3 5 5 10 7 0
Schizophrenia 12 0 0 0 0 6 0 6
Amyotrophic
Lateral
Sclerosis
1 0 0 1 0 0 0 0
Total 72 9 8 10 16 22 10 12

Potential Challenges and Solutions to Overcome

§  Challenge in taking consent involving family members.
§  To overcome this, we train our site personnel on how to
explain the study and keep them updated of the study status.
§  For example, we provide newsletters and email blasts to update site
personnel of the recruitment status and safety data.
§  We put up educational posters of dementia condition at the sites. These
efforts help to reassure subjects and their family members.
§  Care-giver support is needed.
§  Our current trials require weekly blood drawings. To minimize
inconvenience to the caregiver, some of the sites have study nurses to
visit the subjects’ homes for blood draws.

§  Patient inconvenience to attend too many hospital visits as the
majority of them are elderly (travel distances).
§  Emotional swing in elderly person that affects the assessment
of cognitive test. It is important to give subjects and their
family members a sense of familiarity. Hence, sites we select
have low staff turnover and dedicated facilities. This is helpful
in subject retention.
§  Patients are reluctant to draw blood too frequently, which
limits the recruitment in AD studies.
Potential Challenges and Solutions to Overcome (Continued)

§  For our current Alzheimer’s study, recruitment is challenging
because subjects are required a weight above 50kg and do
weekly blood taking. Nonetheless, we managed to recruit
patients because of the following strategies:
§  Meeting / Calls with PI and site staff before SIV to train the team on
eligibility criteria – this is to ensure that the site screens their database
for eligible subjects prior to SIV. This strategy also helped us to have fast
FPI.
§  Motivational visits
§  Newsletters
§  Sharing of best practices among sites. Once the site recruits a patient,
we call them to find out how they recruited the patients and share their
success methodology with other sites
Our Success Stories in Alzheimer’s Disease

§  Pharmaceutical companies developing new CNS products face
special obstacles.
§  Proven experience in a number of CNS studies involving, but
not limited to, Alzheimer’s disease, brain Injury,
Schizophrenia, Progressive Supranuclear Palsy and
Amyotrophic Lateral Sclerosis.
§  Demonstrated ability to manage complex central nervous
system (CNS) trials in Phase II-IV in Asia.
§  Extensive experience with medical feasibility studies,
providing critical data about regions, countries, sites,
investigators, standards/quality of care, and monitoring work.
Proven Approach to CNS Trials

§  With our experience and expertise, we have the ability to
provide proactive solutions to potential clinical trial issues
related to :
§  Design and development of CNS trials
§  Biomarkers and other validated approaches: CNS Toolkit, diagnostic
adjudication
§  Patient recruitment strategy
§  Translation of study material and assessment tools
§  CNS and Rater training internally and site staff
§  Sourcing local vendors e.g. central lab, IWRS, drug depot etc.
Proven Approach to CNS Trials (Continued)

§  Large and ever increasing size of dementia population offering
a large patient pool: e.g. a total of 3,628 Asian subjects have
been pre-screened in our study
§  Provide optimal care for patients (low income, residents in
urban area, limited treatment options, seeking alternative
treatment)
§  Relatively few/little competitive trials for patients to choose
§  Large numbers of patients with dementia living with
caregivers
§  Able to recruit motivated clinical investigators (some are
KOLs) to join international/global clinical trials
§  Conducive hospital infrastructure, healthcare team and ethic/
regulatory environment for clinical research activity
Advantages of Conducting AD Clinical Trials in Asia

§  Protocol criteria deviation (e.g. low BMI of <18, low creatinine
clearance <50 ml/min) in Asia population vs. Caucasian
population for global trials.
§  Less experience of site team in conducting such trials
§  Finding ICH/GCP compliant sites and Pis
§  Caregiver pressures (concerns about the safety of the
products, patient as trial subject, their presence in every
protocol visit etc.)
§  Language/Cultural Barriers
§  Distance for patients to travel for care
§  Frequent or long term follow up of protocol visits cause
inconveniences to patients or caregiver
Key Challenges of Conducting AD Trials in Asia

§  Appropriate protocol design to meet the disease status for Asia population
(e.g. lower BMI etc.)
§  Provide re-training to the investigator or site team
§  Relationship of local CRA with sites and study co-ordinators
§  Motivating investigators by providing additional educational meetings or
publications opportunity
§  Set up referral system with district clinic or healthcare body
§  Producing appropriate educational materials to raise awareness for physicians
and patients/caregivers
§  Advertise through newspaper, radio or poster
§  Arrange appropriate transportation for AD patients
§  Compensation for caregivers’ time
§  Frequent telephone follow up or site visits (occasional) by the study monitor
to the site in order to provide support
§  Newsletter to provide latest recruitment status as well as information (e.g.
safety) about the investigational products.
Overcoming the Challenges

Q & A

ClinActis Webinar: Tackling Dementia & Alzheimer's in Asia Pacific

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