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Evaluating the Efficacy of Eye Training for Alzheimer's Disease with Delusions

Evaluating the Efficacy of Eye Training for Alzheimer's Disease with Delusions An open-label, randomized, controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240356
Enrollment
60
Registered
2024-09-29
Start date
2024-11-07
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Alzheimer disease

Interventions

Participants are randomly allocated using the presence or absence of delusions as an allocation factor and divided into intervention and non-intervention groups. The intervention group will be given e

Sponsors

Sachiko Nakayama
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with probable AD according to the diagnostic criteria of the NINDS-ADARD study group who are attending the outpatient department of neurology at Juntendo Koshigaya Hospital, Juntendo University School of Medicine between the date of study approval and 31 January 2027 AD will be included. The presence or absence of delusions is assessed using the NPIQ for the primary caregiver, with severity of delusion item 1 or more being judged as having delusions and severity = 0 being judged as having no delusions. In addition, subjects will be included if they meet the following conditions (1) Age between 50 and 90 years old at the time of consent (2) MMSE score of 20 or higher (3) The patient must have a caregiver living with him/her who is able to cooperate in the study. The caregiver must be able to come to the hospital at the time of the examination. (4) After receiving a full explanation of participation in this study, the subject must be able to give written consent of his/her own free will based on sufficient understanding.

Exclusion criteria

Exclusion criteria: (1) Newly introduced anti-dementia drug or psychotropic drug within 1 month prior to the start of consent (2) Patient has visual acuity <0.01 or diplopia or visual field defects in both eyes (3) Patient has a history of stroke, (4) Patient is suspected to have cerebrovascular dementia (5) Patients with parkinsonism (6) When complications of other neuropsychiatric disorders are suspected (7) Patient has or has had drug or alcohol dependence (8) Patient has epilepsy or has a history of epilepsy (9) If the subject has a serious uncontrolled systemic disease (heart failure, liver failure, renal failure, vitamin B12 deficiency, hypothyroidism, etc.), and if the subject's systemic condition deteriorates. (10) Other cases in which the principal investigator determines that the subject is inappropriate as a research subject.

Design outcomes

Primary

MeasureTime frame
Amount of change in severity and burden of NPIQ delusional items before and after eye training in the group with delusions.

Secondary

MeasureTime frame
1) To evaluate the differences in each saccade task in the group with delusions compared to the group without delusions. 2) To evaluate the effect of the intervention on the total score of Mini Mental State Examination, the time required for Trail Making Test A and B, the total score of Frontal Assessment Battery, the number of words produced in the word fluency task, and the total score of the shortened Japanese version of Zarit Caregiver Burden Scale before and after the eye training. The effect of the intervention will be evaluated by comparing the change in the total score of the Japanese abbreviated version of the Zarit Caregiver Burden Scale with that of the control group.

Contacts

Public ContactNakayama Sachiko

Department of Neurology, Juntendo University Koshigaya Hospital

snakaya@juntendo.ac.jp+81-48-975-0321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026