Clinical trial • Phase IV • Neurology

DONEPEZIL HYDROCHLORIDE for Parkinson's disease | Parkinson's disease-related mild cognitive impairment (PD-MCI)

Phase IV trial of DONEPEZIL HYDROCHLORIDE for Parkinson's disease | Parkinson's disease-related mild cognitive impairment (PD-MCI).

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Parkinson's disease | Parkinson's disease-related mild cognitive impairment (PD-MCI)
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
05-06-2024
First CTIS Authorization Date
12-06-2024

Trial design

Randomised, donepezil versus placebo (comparator: placebo). product listed: aricept 10mg film-coated tablet (donepezil hydrochloride); trial text does not specify dosing schedule in the submission (product metadata lists max daily dose amount 15 mg).-controlled Phase IV trial in Spain.

Randomised
Yes
Comparator
Donepezil versus placebo (comparator: placebo). Product listed: ARICEPT 10mg film-coated tablet (donepezil hydrochloride); trial text does not specify dosing schedule in the submission (product metadata lists max daily dose amount 15 mg).
Target Sample Size
120
Trial Duration For Participant
365

Eligibility

Recruits 120 Vulnerable populations not selected (isVulnerablePopulationSelected: false). Individuals with legal incapacity, insufficient proficiency in Spanish or the local language, illiteracy, or sensory impairments that impede giving informed consent are excluded. A subject information and informed consent form is listed in the trial documents; participants must be able to give informed consent..

Pregnancy Exclusion
Pregnancy, desire for conception, refusal to use appropriate contraceptives during the study period and up to 6 months after, or lactation (see section 9.6).
Vulnerable Population
Vulnerable populations not selected (isVulnerablePopulationSelected: false). Individuals with legal incapacity, insufficient proficiency in Spanish or the local language, illiteracy, or sensory impairments that impede giving informed consent are excluded. A subject information and informed consent form is listed in the trial documents; participants must be able to give informed consent.

Inclusion criteria

  • {"criterion_text":"- Age between 50 and 80 years (inclusive).\n- Diagnosis of Parkinson's disease based on MDS criteria\n- Neuroimaging compatible with Parkinson's disease\n- Hoehn and Yahr stage (H&Y) I-III (inclusive).\n- Persistent subjective cognitive complaints in the 6 months prior to screening.\n- Diagnosis of Parkinson's disease-related mild cognitive impairment (PD-MCI) according to MDS PD-MCI criteria: Level I: MoCA ≤24 and ≥20(46) and Level II: 2/10 neuropsychological tests altered with a cutoff of 1.5 Standard Deviations(47,48).\n- Duration of PD-MCI for at least 3 months prior to screening.\n- Stable dopaminergic treatment in the 4 weeks prior to screening."}

Exclusion criteria

  • {"criterion_text":"- Criteria for dementia associated with Parkinson's disease\n- Insufficient proficiency in Spanish or the local language, illiteracy, sensory impairments (vision, hearing), legal incapacity, or any other mental, physical, or social condition that impedes giving informed consent or completing assessments adequately.\n- History of symptomatic orthostatic hypotension.\n- Pregnancy, desire for conception, refusal to use appropriate contraceptives during the study period and up to 6 months after, or lactation (see section 9.6).\n- Any significant abnormalities in medical history, examination, vital signs, laboratory tests, or ECG that, at the investigator's discretion, contraindicate participation in the study.\n- Severe motor complications (moderate to severe motor fluctuations defined as a score >1 on item 42 of Part IV of the MDS UPDRS; or disabling dyskinesias defined as a score >1 on item 36 of Part IV of the MDS UPDRS).\n- History of Deep Brain Stimulation.\n- Active psychosis or treatment with antipsychotic medications, major hallucinations, HADS score ≥11, active impulse control disorder, or other severe active behavioral disorders.\n- Active treatment with anticholinergics, acetylcholinesterase inhibitors, or other systemic cholinergic enhancers, neuroleptics, potent CYP3A4 or 2D6 inhibitors, enzyme inducers, or drugs prolonging the QTc interval (see section 6.7).\n- Hypersensitivity or intolerance to donepezil, piperidine derivatives, lactose, or any of the excipients of the active drug.\n- History or impression, at the investigator's discretion, of poor therapeutic compliance.\n- Unstable medical or surgical condition, or life expectancy of <1 year.\n- Brain condition that may contribute to cognitive decline (history of stroke, brain tumor, neurosurgical intervention, etc.), including the presence of grade III leukoaraiosis on brain neuroimaging."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Parkinson's Disease-Cognitive Rating Scale (PD-CRS)\n- Parkinson's Disease-Cognitive Functional Rating Scale (PD-CFRS)","definition_or_measurement_approach":"Primary endpoints assessed as cognitive performance measures over 12 months (change from baseline to 12 months) in PD-CRS and PD-CFRS as part of the 12-month efficacy evaluation."}

Secondary endpoints

  • {"endpoint_text":"- Trail Making Test A (TMT-A)\n- Digit Span directo (DSd)\n- Trail Making Test B (TMT-B)\n- Phonemic fluency\n- Boston Nomination Test reduced (BNTr)\n- Semantic fluency\n- Free and Cued Selective Reminding Test (FCSRT)\n- Figura compleja de Rey-Osterrieth (ROCF) y recuerdo de ROCF (rROCF)\n- Judgement of Line Orientation (JLO)\n- Hospital Anxiety and Depression Scale (HADS)\n- Starkstein Apathy Scale (AS)\n- Neuropsychiatric Inventory (NPI)\n- MDS UPDRS-I y -II\n- Schwab & England scale (S&E):\n- 8-item Parkinson’s Disease Questionnaire (PDQ-8)\n- Clinical Global Impressions (CGI-S y CGI-I)\n- Patients Global Impression of Change (PGIC)","definition_or_measurement_approach":"Secondary endpoints measured as changes from baseline to 12 months on the listed cognitive, neuropsychiatric, motor and quality-of-life scales/tests (as specified in the secondary objectives)."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
22
Consent Approach
Written informed consent required from participants. Subject information and informed consent form is listed among trial documents. Participants must be proficient in Spanish or the local language; individuals with legal incapacity or conditions that impede giving informed consent are excluded. No mention of assent or age-specific consent documents for minors (paediatric population not included).

Geography

Total Number Of Sites
21
Total Number Of Participants
120

Spain

Earliest CTIS Part Ii Submission Date
17-01-2024
Latest Decision Or Authorization Date
14-04-2025
Processing Time Days
453
Number Of Sites
21
Number Of Participants
120

Sites

Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Neurology
Contact Person Name
Lydia Vela Desojo
Contact Person Email
lvela@fhalcorcon.es
Site Name
Hospital La Milagrosa S.A.
Department Name
Neurology
Contact Person Name
Víctor Gómez Mayordomo
Contact Person Email
vicmayordomo@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Neurology
Contact Person Name
Juan Carlos Martínez
Contact Person Email
jcmcastrillo@gmail.com
Site Name
Hospital De Tortosa Verge De La Cinta
Department Name
Neurology
Contact Person Name
Sonia Escalante
Contact Person Email
sescalant@yahoo.es
Site Name
Hospital Universitario Donostia
Department Name
Neurology
Contact Person Name
Javier Ruiz Martínez
Site Name
Hospital General Universitario De Elche
Department Name
Neurology
Contact Person Name
María Álvarez Saúco
Contact Person Email
mariaalsa@hotmail.com
Site Name
Hospital Universitario De Navarra
Department Name
Neurology
Contact Person Name
Itziar Gastón Zubimendi
Site Name
Hospital Universitario Central De Asturias
Department Name
Neurology
Contact Person Name
Marta Blázquez Estrada
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Contact Person Name
Oriol de Fàbregues
Contact Person Email
odefabregues@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurology
Contact Person Name
Jon Infante Ceberio
Contact Person Email
jon.infante@scsalud.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurology
Contact Person Name
Pablo Mir
Contact Person Email
pmir@us.es
Site Name
Hospital De Sant Joan Despi Moisés Broggi
Department Name
Neurology
Contact Person Name
Asunción Ávila Rivera
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Contact Person Name
Jaime Kulisevsky Bojarski
Contact Person Email
JKulisevsky@santpau.cat
Site Name
Hospital Universitario De La Princesa
Department Name
Neurology
Contact Person Name
Lydia López Manzanares
Contact Person Email
lydialopez@hotmail.com
Site Name
Hospital Universitario De Burgos
Department Name
Neurology
Contact Person Name
Esther Cubo
Contact Person Email
esthercubo@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurology
Contact Person Name
Pau Pastor
Contact Person Email
pastorpau@gmail.com
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Neurology
Contact Person Name
Pedro J. García Ruiz
Contact Person Email
pgarcia@fjd.es
Site Name
Hospital Universitario De Toledo
Department Name
Neurology
Contact Person Name
Nuria López Aristegui
Contact Person Email
nlariztegui@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Contact Person Name
Julio Dotor
Contact Person Email
juliodotor@gmail.com
Site Name
Hospital Universitario De Cabueñes
Department Name
Neurology
Contact Person Name
Jessica González
Contact Person Email
jessardura@yahoo.es
Site Name
Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña
Department Name
Neurology
Contact Person Name
Diego Santos
Contact Person Email
diegosangar@yahoo.es

Sponsor

Primary sponsor

Full Name
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
ARICEPT 10mg comprimidos recubiertos con película
Active Substance
DONEPEZIL HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number 61.870 (authorisationCountryCode: ES)
Maximum Dose
15 mg

Related trials

Other published trials that may interest you.