Improve cognitive function with training

Trial ID
NCT06323278
Official Title
Evaluation of the Cognitive Stimulation Treatment in Patients With Parkinson's Disease
Goal
Improve cognitive function with training
Status
RECRUITING
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study Type
OBSERVATIONAL
Enrollment
68 participants
Conditions
Parkinson Disease
Interventions
Cognitive training

Summary For Families

The goal is to see whether a structured cognitive stimulation program can help people with Parkinson's who have mild cognitive impairment, by maintaining or improving memory, attention, planning, and everyday thinking. The approach uses regular, non-drug cognitive training sessions,guided exercises and activities meant to stimulate neural networks and strengthen thinking skills,and it is offered alongside usual care, so it does not replace or change levodopa or other medications. The trial is looking for adults 18 to 80 with a Parkinson's diagnosis who have had genetic screening, a MoCA raw score between about 15.5 and 22.23, have given consent, are not diagnosed with dementia, and are not treated with deep brain stimulation.

Locations

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Frequently Asked Questions

What is this trial testing?
This trial is studying Cognitive training. The goal is to see whether a structured cognitive stimulation program can help people with Parkinson's who have mild cognitive impairment, by maintaining or improving memory, attention, planning, and everyday thinking. The approach uses regular, non-drug cognitive training sessions,guided exercises and activities meant to stimulate neural networks and strengthen thinking skills,and it is offered alongside usual care, so it does not replace or change levodopa or other medications. The trial is looking for adults 18 to 80 with a Parkinson's diagnosis who have had genetic screening, a MoCA raw score between about 15.5 and 22.23, have given consent, are not diagnosed with dementia, and are not treated with deep brain stimulation.
Who can participate?
Participants must be between 18 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 4 years and 11 months.
Will I get the real drug or a placebo?
It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
How often will I need to visit the study site?
Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
Can I leave the trial if I change my mind?
Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
Will travel or parking be reimbursed?
Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
Can my spouse or care partner come with me to visits?
In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.

Related Reading

View on ClinicalTrials.gov