Case Study: Dementia

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Case Study:
Dementia CNS

ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality
standards to regional specificities. ClinActis is flexible in our approach to work scope and budgeting and
contracting process.
Delivering Quality to Our Clients
ClinActis is committed to implementing international standards in clinical trials. Our ability to deliver high
quality results to our clients is based on recruiting and maintaining the best talent within our
organization. ClinActis’ senior management is fully accountable for the quality of deliverables to our
clients.
Your Proactive Clinical Research Partner in Asia Pacific

ClinActis Pte Ltd is a full service CRO
providing clinical trial services to the
pharmaceutical, medical device, medical
nutrition and biotech companies in Asia
Pacific. Established in 2009, ClinActis Pte Ltd
is headquartered in Singapore.
ClinActis Value Proposition
ClinActis is a multicultural company. As such,
the team is able to communicate effectively
with international clients.

Mission and Vision

With headquarters based in Asia, all corporate
decisions are made within the region, in order to
better anticipate our client needs and adapt to local
specificities.
Vision
Our vision is to become the reference CRO
specialized in conducting clinical research in Asia
Pacific, offering state of the art quality services, with
cost effective solutions.
We strive to employ people with genuine expertise
in the region and with a passion for excellence, to
work with our clients in the most pro-active way, and
to build a relationship based on trust, transparency
and strong ethics.
Mission
Our mission is to provide our clients with unique
and dynamic expertise in applying global drug
development standards to the specificities of
each country in the Asia Pacific region.

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.
About Our Founder
His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology
company 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.

Operational Expertise – Regional Footprint
ClinActis Experience
§  33 years experience in clinical
research in pharmaceutical and
biotechnology companies as well as
CROs
§  27 years experience in Asia Pacific,
including Australia/New Zealand,
China, Malaysia, Hong Kong, India,
Indonesia, the Philippines,
Singapore, South Korea, Taiwan,
Thailand, Japan and Vietnam
§  Extensive knowledge of regulatory
frameworks, best KOLs and sites
across the region
§  Vast therapeutic experience including
Oncology, Infectious diseases, CNS,
Cardiovascular, Endocrinology, and
Respiratory

Alzheimer’s Disease Clinical Trial Considerations in Asia Pacific
§  The total population of the Asia Pacific region in 2015 was estimated from
United Nations data at 4.4 billion. The population aged 60 years and above
was 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 are the most common types of
dementia.
§  The number of those with dementia was forecasted to increase in the Asia
Pacific region from 13.7 million people in 2005 to 64.6 million by 2050.

PREVALENCE AND INCIDENCE, ASIA PACIFIC
2005 2020 2050
‘000 people Prevalence
ce
Incidence Prevalence Incidence Prevalence 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
Hong Kong 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
New Zealand 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

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.
§  At the present time 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.
§  The 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 the 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 their clinical guidelines, health authorities in Singapore 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.
§  Potential clinical sites in Singapore are:
1. Singapore General Hospital
Geriatric Medicine Department, Memory Clinic
2. Tan Tock Sing Hospital
Geriatric Medicine Department
3. Changi General Hospital
Geriatric Medicine Department
4. National University Hospital
Neurology department

Taiwan
§  According to available data, 10.63% of the population in Taiwan is older adults, and 4.8% of older
adults have dementia.
§  Around 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.
§  The healthcare system is 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.
§  The 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)
§  There are 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.
1. Dr. Jong-Ling Fuh / Taipei Veterans General Hospital
2. Dr. Chin-Chang Huang / Chang-Gung Medical Foundation - Linkou branch
3. Dr. Yu-Wan Yang / China Medical University Hospital
4. Dr. Chiung-Chih / Chang Chang Gung Memorial Hospital, Kaohsiang
§  We can safely assume that there are other sites based outside Taipei that can also be
involved and offer a solid patient potential.

Korea
§  Up to 10% of the elderly in Korea suffer from dementia. Further, 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.
§  The healthcare system is well organized to take care of Alzheimer’s patients:
Primary Care: Private Clinic
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).
Public Health Centers
25 Dementia Centers are operating as Dementia Program in Seoul City. Preventing program &
education and dementia health exams are conducted in these centers. Dementia Patients are
registered into the Dementia Registry database managed by Seoul City. Dedicated doctors are
working in the centers. Other provinces are in charge of public Health Centers.
General Hospital
If dementia medication or cognitive activities are necessary for the patients, they are referred to
the General Hospital. The following have a specific Center of dementia or Parkinson Disease in
Seoul: Samsung Medical Center, Asan Medical Center, Severance Hospital, Seoul National
University. Other provinces have a specific center in National University Hospital.

Korea (Continued)
§  The 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.
§  The standard therapy should also include a change of lifestyle and environment,
cognitive activities & training, and behavior training.
§  Patients are also provided with a health caregiver or may use hospitalized facilities.

ClinActis CNS and ADExperience
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 ADExperience (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

Process in Asia Pacific when diagnosis with Dementia occurs
§  Patient will be referred by GP to specialist for further evaluation of the
condition.
§  This management is mainly applicable to developed countries (like Australia,
Singapore, Korea, Taiwan, Hong Kong, Malaysia) where the:
-  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.

Countries to consider for Clinical Trials in AD in Asia Pacific

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

Site Capabilities in Asia Pacific

§  We can use highly skilled and experienced sites; PI and site staffs who are
currently taking part in our on-going Alzheimer study in the region. The PIs and
team are well trained professionals for cognitive assessment. The team in our
on-going study has 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) helps ensure raters remain updated on the trial.
§  If MRI/CT scans are required, it is best to have centralized readers. Our sites
are familiar with online portal to upload scans for centralized reviewer.

Benefits of conducting AD study in Asia Pacific

§  We have good patient pools in the region, e.g. Singapore pre-screened
~800 and Hong Kong pre-screened ~1000 of patients with suspected
mental disorder/dysfunction in their clinic setting within 3-6 months.
§  Less costly than US/European countries
§  Trained and experienced site personnel and CRO team

Potential pitfalls and ClinActis measures to overcome them

§  The 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. Also, 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 trial requires weekly blood taking. To minimize inconvenience to
the caregiver, some of the sites have study nurses to visit the subjects’ homes
for blood taking.
§  Patient inconvenience to attend too many hospital visits as the majority of
them are elderly.

Potential pitfalls and ClinActis measures to overcome them
(Continued)

§  Emotional swing in elderly person that affect the assessment of cognitive test.
It is important to give subjects and their family members a sense of familiarity.
Hence, sites we selected 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.

ClinActis success stories in Alzheimer’s Disease

§  For the current Alzheimer’s study, recruitment is challenging because
subjects are required to be 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 would
call them to find out how they recruited the patients and share their success
methodology with other sites.

Contact Us for More Information

Imen Jelassi, PharmD, MSc
EU Director, Strategic Relations
M: +33 6 28 11 13 71
E: ijelassi@clinactis.com
Bill Van Nostrand
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com

Case Study: Dementia

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