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Donepezil for Visuospatial dysfunction in Mild Cognitive Impairment

A Single-center, Randomized, Parallel design, Phase 2 trial to Evaluate the Efficacy of Donepezil for improvement in visuospatial abilities in Patients with Mild Cognitive Impairment

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0006236
Enrollment
70
Registered
2021-06-10
Start date
2021-07-22
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Intervention group 1 takes Donepezil, 5mg once daily, orally for the first 4 weeks, and then increases to 10mg for the next 8 weeks, taking it orally once daily. Intervention group 2 does not

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. =60 and <90 years of age 2. Mild cognitive impairment (Peterson Criteria) 3. More than 6 years of education (more than elementary school graduation) 4. Normal visual acuity 5. Completion of a dementia work-up including neuropsychological tests and MRI 6. Amyloid PET scan positive 7. K-MMSE =19 points

Exclusion criteria

Exclusion criteria: 1. Structural lesions (such as territorial infarction, intracranial haemorrhage, brain tumour, hydrocephalus) 2. Severe white matter hyperintensities (WMH) observed on brain MR image (severe WMH on MRI was defined as a cap or a band =10 mm as well as a deep white matter lesion =25 mm as modified from the Fazekas ischemia criteria) 3.When the following drugs are administered: rivastigmine, galantamin, and memantine among Cholinesterase inhibitors 4. Patients with neurological abnormalities that may cause memory impairment on medical examination 5. Persons with a history of one-axis psychiatric disorders, including intellectual disabilities, schizophrenia, alcoholism, and bipolar desorder 6. Those who have a history of malignant diseases(cancer) within the last 3 years. However, Cerviacl Carcinoma in Situ or Nonmelanoma Skin Cancer is excluded. 7. Those who have undergone cerebrovascular surgery such as brain surgery or carotid artery surgery 8. Those who have difficulty breathing when sitting still 9. Those who have had a memory disorder, language disorder, or problem solving ability disorder for more than 2 hours after a heart attack 10. Persons with a history of hospitalization for mental or emotional problems within the last 5 years 11. Those with a history of abuse of drugs within the last 5 years 12. Those with a history of receiving treatment for alcoholism within the last 5 years 13. Those who have lost consciousness for more than 1 hour due to causes other than general anesthesia 14. Those who have been hospitalized for a head injury 15. Those who are unable to read ordinary letters even with glasses due to decreased vision 16. Those who have difficulty understanding conversations due to hearing impairment even when wearing hearing aids 17. Those who determine that the investigator is unsuitable for participation in the clinical trial

Design outcomes

Primary

MeasureTime frame
Eye-tracking metrics

Secondary

MeasureTime frame
Cognitive function test result;Digital pen data

Countries

Korea, Republic of

Contacts

Public ContactSe Hee Koo

Jeonbuk National University Hospital

kshpth@naver.com+82-63-250-1590

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 13, 2026