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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04739423




Registration number
NCT04739423
Ethics application status
Date submitted
29/01/2021
Date registered
4/02/2021
Date last updated
31/05/2023

Titles & IDs
Public title
A Study of CST-103 Co-administered With CST-107 in Subjects With Neurodegenerative Disorders
Scientific title
A Phase II, Randomized, Placebo-Controlled, Double-Blind, Crossover, Study of the Pharmacodynamic Effects of CST-103 Co-administered With CST-107 on the Central Nervous System in Subjects With Neurodegenerative Disorders
Secondary ID [1] 0 0
CST103/CST107-CLIN-011
Universal Trial Number (UTN)
Trial acronym
CLIN-011
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment, Lewy Body Dementia, Parkinson's Disease Rapid Eye Movement Sleep Behavior Disorder, Parkinson's Disease Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CST-103, CST-107, matching placebo

Experimental: CST-103/CST-107 to Placebo - Subjects will receive daily doses of CST-103 co-administered with CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by matching placebo for CST-103 and matching placebo for CST-107 for 14 days.

Experimental: Placebo to CST-103/CST-107 - Subjects will receive daily doses of matching placebo for CST-103 co-administered with matching placebo for CST-107 for 14 days, followed by a washout period of no drug for 14 days, followed by daily doses of CST-103 co-administered with CST-107 for 14 days.


Treatment: Drugs: CST-103, CST-107, matching placebo
CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Negative Emotional Bias in the Facial Expression Recognition Task (FERT)
Timepoint [1] 0 0
Days 1, 7, and 14 of each Treatment Period (Two 14-day periods)
Primary outcome [2] 0 0
Change from Baseline in Cognitive Fluctuations
Timepoint [2] 0 0
Screening, Days 1 and 14 of each Treatment Period (Two 14-day periods)
Secondary outcome [1] 0 0
Change from Baseline in CANTAB Cognitive Assessments
Timepoint [1] 0 0
Screening, Days 1, 7, 14 of each Treatment Period (Two 14-day periods)
Secondary outcome [2] 0 0
Digital wearable device (BioStamp)
Timepoint [2] 0 0
Screening, Days 1-14 of each Treatment Period (Two 14-day periods)

Eligibility
Key inclusion criteria
Subjects with RBD+PD:

- Male or female subjects = 40 and = 80 years of age, at time of informed consent.

- Diagnosed with Parkinson's Disease, as defined by the United Kingdom Parkinson Disease
Brain Bank criteria, associated with REM sleep behavior disorder (RBD+PD)

- Modified Hoehn & Yahr = stage 1 and = stage 3 during "On" period as documented in the
3 months prior to Screening or completed at Screening.

- Montreal Cognitive Assessment (MoCA) score = 18 and = 28.

- Hospital Anxiety and Depression Scale (HADS) Depression Sub-score = 8.

Subjects with MCI:

- Male or female subjects = 50 and = 80 years of age, at time of informed consent.

- Meet the criteria for amnestic Mild Cognitive Impairment (MCI) as per the National
Institute on Aging-Alzheimer's Association core clinical criteria.

- Montreal Cognitive Assessment (MoCA) score = 18 and = 26.

- No dementia according to the International Classifications of Diseases (ICD)-10 and
Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV.

- Memory complaint reported by the subject or his/her partner, family member or
caregiver.

- Score of greater than or equal to one standard deviation below age and educational
norms in the Digit Symbol Substitution Test (DSST) during Screening.

- Cognitive decline not primarily caused by vascular, traumatic, or medical problems.

- HADS Depression Sub-score = 8.

Subjects with Dementia with Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD):

- Male or female subjects = 50 and = 80 years of age, at time of informed consent.

- Diagnosis of dementia associated with Dementia with Lewy Bodies or Parkinson's disease
(PDD).

- Documented cognitive fluctuations endorsed on the Dementia Cognitive Fluctuation Scale
(DCFS) with a combined score of =8 in items 4, 11, 12 and 14.

- Montreal Cognitive Assessment (MoCA) score = 18 and = 26.

- Have informant or caregiver throughout the study who will submit written consent to
cooperate with this study, who routinely accompanies and/or stays with subject 12
hours or more a week, assists with treatment compliance, provides assessments and is
able to escort the subject on required visits to study institution.

- Modified Hoehn & Yahr = stage 1 and = stage 3 during "On" period as documented in the
3 months prior to Screening or completed at Screening.

- Stable concomitant medical and/or psychiatric illnesses in the judgement of the PI.

For ALL Subjects:

- Unless confirmed to be azoospermic (vasectomized or secondary to medical cause), males
must agree to use a male condom from Day 1 throughout the study when having
penile-vaginal intercourse with a woman of childbearing potential who is not currently
pregnant.

- Females of childbearing potential (i.e., not postmenopausal or surgically sterile) who
have a male partner must have a negative serum pregnancy test result and must agree to
one of the following from start of Screening through 30 days after the last study
medication administration: use a reliable method of birth control, or monogamous
relationship with a male partner of confirmed sterility, or practice complete
abstinence.

- Females of non-childbearing potential may be enrolled if it is documented that they
are postmenopausal.

- Body weight greater or equal to 50 kg and body mass index (BMI) between 18 and 35
kg/m2, inclusive at Screening.

- Stable medical conditions for 3 months prior to Screening visit (e.g., controlled
hypertension, dyslipidemia).

- Willing to follow the protocol requirements and comply with protocol restrictions.

- Capable of providing informed consent and complying with study procedures. Subjects
who are unable to provide consent may use a Legally Authorized Representative.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy.

- Pulmonary disease, including asthma if requiring the use of a ß2-Adrenergic
bronchodilator, or evidence of clinically significant moderate or severe pulmonary
symptoms.

- Clinical signs indicating syndromes such as corticobasal degeneration, supranuclear
gaze palsy, multiple system atrophy, chronic traumatic encephalopathy, signs of
frontal dementia, history of stroke, head injury or encephalitis, cerebellar signs,
early severe autonomic involvement, or Babinski sign.

- Current evidence or history in past two years of epilepsy, focal brain lesion, head
injury with loss of consciousness or meeting DSM-IV diagnostic criteria for psychotic
disorders.

- Evidence of any significant clinical disorder or laboratory finding (or in the case of
potassium levels below normal range) that renders the participant unsuitable for
receiving an investigational drug.

- History of malignant disease, including solid tumors and hematologic malignancies
(except basal cell and squamous cell carcinomas of the skin that have been completely
excised and are considered cured).

- Any clinically significant illness or disease as determined by medical and surgical
history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory
assessments conducted at Screening.

- Clinically significant abnormalities of ECG, including QTcF > 450 ms, for males and
QTcF > 470 ms for females, and/or HR < 50 beats per minute, or evidence of clinically
significant bundle branch blocks, as indicated by 12-lead ECG.

- Calculated creatinine clearance of =70 mL/min according to the Cockcroft-Gault
equation.

- Current use of any prohibited prescription medication, over-the-counter medication, or
herbal supplements/products.

- Prior treatment with any investigational drug =90 days prior to dosing (Day 1), or =5
half-lives of the drug (whichever is longer), or current enrollment in any other study
treatment or disease study, except for observational studies.

- Known or suspected alcohol or substance abuse within the past 12 months and/or
positive test for alcohol or drugs of abuse.

- Active suicidal ideation within 3 months prior to study Screening.

- Positive screening test for hepatitis C antibody (HCV Ab) or current hepatitis B
infection (defined as positive for hepatitis B surface antigen [HBsAg] at Screening).

- Positive screening test for human immunodeficiency virus (HIV).

- Current infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

- Contraindications to wearing the BioStamp digital device sensors, which include but
are not limited to implanted pacemakers, defibrillators, or other active implantable
devices.

- Known allergies or hypersensitivities to adhesives or hydrogel.

- Other reasons for which the PI considers it is not in the best interest of the
participant to undertake the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
The University of Sydney - Sydney
Recruitment hospital [2] 0 0
Wesley Medical Research Ltd - Brisbane
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment postcode(s) [2] 0 0
QLD 4066 - Brisbane
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Barnsley
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Lancashire
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CuraSen Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, randomized, placebo-controlled, double-blind, crossover study on the CNS
and pharmacodynamic effects of CST-103 co-administered with CST-107 in 4 subject populations
with Neurodegenerative Disorders.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04739423
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
CuraSen Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04739423