Study on Donepezil for Mild Cognitive Impairment in Parkinson’s Disease Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called on individuals with who experience mild cognitive impairment. Parkinson’s disease is a condition that affects movement and can also impact memory and thinking skills. The medication being tested, donepezil, is usually used to treat Alzheimer’s disease, but researchers are exploring its potential benefits for people with Parkinson’s disease.

The purpose of the study is to evaluate the safety and effectiveness of donepezil in improving cognitive performance over a period of 12 months. Participants in the study will be randomly assigned to receive either donepezil or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will take the medication orally in the form of a film-coated tablet. The trial will involve regular assessments to monitor cognitive abilities and overall health. These assessments will help determine if donepezil can provide cognitive benefits for those with mild cognitive impairment associated with Parkinson’s disease. The study aims to provide valuable insights into potential new treatment options for managing cognitive symptoms in Parkinson’s disease.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age between 50 and 80 years, a diagnosis of Parkinson’s disease, and mild cognitive impairment related to Parkinson’s disease.

Neuroimaging and cognitive assessments are conducted to ensure compatibility with the study requirements.

2 randomization and initial assessment

Participants are randomly assigned to receive either the medication donepezil hydrochloride or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

Initial cognitive and functional assessments are conducted using scales such as the Parkinson’s Disease-Cognitive Rating Scale (PD-CRS) and the Parkinson’s Disease-Cognitive Functional Rating Scale (PD-CFRS).

3 medication administration

Participants take the assigned medication orally in the form of a film-coated tablet called ARICEPT 10mg once daily.

The duration of medication administration is 12 months, during which participants continue their regular dopaminergic treatment.

4 ongoing assessments

Throughout the 12-month period, participants undergo regular assessments to monitor cognitive performance and overall health.

Secondary assessments include tests such as the Trail Making Test, Digit Span, and various fluency and memory tests, as well as evaluations of mood and daily functioning.

5 final assessment and conclusion

At the end of the 12-month period, a final assessment is conducted to evaluate the efficacy and safety of the medication.

The study concludes with a comprehensive analysis of the collected data to determine the impact of donepezil on cognitive performance in participants with mild cognitive impairment associated with Parkinson’s disease.

Who Can Join the Study?

Age between 50 and 80 years, including both ages.
Have a diagnosis of Parkinson’s disease based on specific criteria set by the Movement Disorder Society (MDS).
Have brain imaging results that are consistent with Parkinson’s disease.
Be in stages I to III of the Hoehn and Yahr scale, which is a way to describe how advanced Parkinson’s disease is.
Have ongoing personal concerns about memory or thinking problems for at least 6 months before the study starts.
Have a diagnosis of mild cognitive impairment related to Parkinson’s disease, which means having some memory or thinking issues but not severe enough to be dementia. This is determined by specific tests, including a MoCA score between 20 and 24 and changes in 2 out of 10 neuropsychological tests.
Have had mild cognitive impairment related to Parkinson’s disease for at least 3 months before the study starts.
Have been on a stable treatment for Parkinson’s disease using medications that increase dopamine levels for at least 4 weeks before the study starts.

Who Cannot Join the Study?

Individuals who do not have a diagnosis of Parkinson’s disease cannot participate.
Participants must be within the specified age range, which typically includes adults and older adults.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals who are considered part of a vulnerable population, such as those unable to give informed consent, are not included.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital La Milagrosa S.A.	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Area De Salud De Burgos Y Soria	Burgos	Spain
Hztkszsm Uuszeqpvwhcqp Dd Ln Pzzyvlop	Madrid	Spain
Hentujue Udivaghvsmmix Mojieih Dm Vxilkmmubz	Santander	Spain
Hyygbhpb dw Sgfu Jltk Ddjdc Muuebz Byisqm	Sant Joan Despi	Spain
Hmlriljn Uakzoabydvbvh Dahctxnr	Donostia / San Sebastian	Spain
Hkvtmzdv Ubgjbhytetgto Dt Cnlqguid	Gijon	Spain
Hmoybsdk Dd Ll Skwmw Cpuc I Shrd Pto	Barcelona	Spain
Hcttholf Ursaaktrisajs Heklkxpp Tbegc y Prxfwm Infupzfb Cehxoa deomkenlzfferecif (uhrr	Badalona	Spain
Hoofonhy dn Tecndug Vfnic df lq Cmnmt	Tortosa	Spain
Hqalwxbt Vdnn dsjrfsdg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	21.09.2023

Trial locations

Investigated drugs:

Donepezil Hydrochloride

Donepezil is a medication used in this clinical trial to evaluate its effectiveness and safety in improving cognitive performance in individuals with mild cognitive impairment associated with Parkinson’s disease. It works by increasing the levels of a certain natural substance in the brain, which may help improve memory, awareness, and the ability to function.

Investigated diseases:

Parkinson's disease

Parkinson’s disease – Parkinson’s disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and changes in speech and writing. Non-motor symptoms, such as cognitive impairment, mood disorders, and sleep disturbances, can also occur. The progression of symptoms varies among individuals, and the disease typically advances over several years.

Trial ID:

2024-510959-35-00

Protocol code:

IIBPS-DON-2022-43

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Donepezil for Mild Cognitive Impairment in Parkinson’s Disease Patients

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