Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease.

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2016-000679-25-ES
• Date of registration: 18/03/2016
• Prospective Registration: Yes
• Primary sponsor: INSTITUT DE RECERCA HSCSP
• Public title: Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease.
• Scientific title: A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study.
• Date of first enrolment: 31/05/2016
• Target sample size: 56
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000679-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: UICEC Sant Pau
• Affiliation: Institut de Recerca HSCSP

• Name: UICEC Sant Pau
• Affiliation: Institut de Recerca HSCSP

Key inclusion & exclusion criteria

Inclusion criteria:
a. Patient able to understand, sign, and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures.
b. Outpatients of both genders in ages between 40 and 80 years.
c. Patients diagnosed of Parkinson?s disease (Movement Disorder Society PD Criteria)
d. Patients with a Hoehn and Yahr stage I-III
e. Patients diagnosed of mild cognitive impairment associated to Parkinson?s Disease (PD-MCI criteria based on Movement Disorder Society task force guidelines).
f. Patients with a Montreal Cognitive Assessment (MoCA) rating scale score 20-25 inclusive.
g. Patients diagnosed of Parkinson?s disease with stable dopaminergic treatment in the last 4 weeks.
h. Patient able and willing to comply with study procedures as per protocol.
i. Computerized tomography (CT) or magnetic resonance imaging (MRI) in the last 18 months compatible with the diagnosis of Parkinson?s disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion criteria:
a. Illiterate patient
b. Marked visual impairing or hearing loss.
c. History of cardiac, hematologic, hepatic, renal, pancreatic, metabolic, respiratory, gastrointestinal, endocrinologic, or neurologic system or a tumor that is clinically significant for their participation in the study.
d. Presence of significant motor complications (moderate or severe wearing off defined as score >1 on item 42 of UPDRS part IV) or disabling dyskinesia (defined as score ? 1 on item 36 of UPDRS part IV).
e. History of DBS surgery.
f. Patient with a diagnosis of PD Dementia (probable, possible) according to the Clinical Diagnostic Criteria for Dementia Associated with PD.
g. Patients with active psychosis or major hallucinations, severe depression or delirium.
h. Patients with symptomatic hypotension, hypovolemia or contraindications for taking antihypertensive medications.
i. Patients whose renal function depends on Renin Angiotensin System:
- Patients with cardiac failure class III or IV of the NYHA classification.
- Patients with unilateral or bilateral renal artery stenosis.
j. Patients taking angiotensine-receptor blockers, angiotensin-converting enzyme inhibitors or potassium-sparing diuretics.
k. Patients previously treated with candesartan.
l. Patients with hereditary galactose intolerance, glucose or galactose malabsortion
m. Patients taking lithium.
n. Patients taking acetilcholinesterase inhibitors, anticholinergic medication or dopamine receptor blockers.
o. Patients who were on experimental treatments in the last 2 months previous to selection period.
p. Patients presenting with one of the following conditions:
- Life expectancy < 6 months
- Any severe and/or uncontrolled medical condition
q. Patients with history of poor compliance or history of drug/alcohol abuse, or current drug/alcohol abuse that might interfere with the ability to comply with the study protocol or give informed consent
r. Pregnancy or breastfeeding.
s. Patients with evidence of severe vascular pathology or white matter diffuse involvement in CT or MRI.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Parkinson's Disease

Intervention(s)

Trade Name: Parapres
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Absolute change in Parkinson?s disease-Cognitive Rating Scale score

Secondary Objective: Secondary objectives are analysis of changes in serum biomarkers of neuroinflammation as well as an assessment of the effect of candesartan in executive function, functional, mood and motor scales compared to placebo

Timepoint(s) of evaluation of this end point: 24 weeks

Main Objective: 1. Security: control thorough laboratory tests, vital signs including blood pressure and heart rate, and physical examination findings including electrocardiogram.

2. Efficacy: assessed thorough analysis of Parkinson?s Disease-Cognitive Rating Scale change from baseline to 24 weeks after treatment with candesartan, compared to placebo.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks

Secondary end point(s): - Absolute change in executive function scales: Behavioral Assessment of Dysexecutive Syndrome (BADS) and Tower of London (ToL), from baseline to week 24.

- Absolute change in functional scales: Parkinson?s disease-Cognitive Functional Rating Scale, Schwab & England and 39-item Parkinson's Disease Questionnaire scores, from baseline to week 24.

- Absolute change in mood scales: Starkstein Apathy Scale (AS) score and Hospital Anxiety and Depression Scale (HADS) score, from baseline to week 24.

- Absolute change in motor state assessed by Unified Parkinson?s disease Rating Scale-part III, from baseline to week 24.

- Absolute change in serum biomarkers: advanced glycosylation end products and AT1R antibodies, from baseline to week 24.

Secondary ID(s)

IIBSP-CAN-2016-16

Source(s) of Monetary Support

Institut de Recerca HSCSP

Ethics review

Status: Approved
Approval date:
Contact: