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

JRCT ID: jRCT1030240356

Registered date:29/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Alzheimer disease
• Date of first enrollment: 07/11/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): 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 eye training for 5 minutes per session, twice a day. A training menu including horizontal and vertical smooth-following movements (1 min total), horizontal and vertical visually guided saccade tasks (1 min total), horizontal and vertical anti-saccade tasks (2 min total) and memory-guided saccade tasks (1 min total) was created using the app Focus Bilder ( NeurdSolutions, USA), converted into an MP4 video of approximately 5 minutes including the instructional audio, and watched on a tablet with the support of a carer. While watching the video, the patient moves his/her gaze as instructed and performs eye training twice a day for five minutes each time, twice a day at home. The implementation status will be determined by the app usage history in the tablet's screen time. The intervention period will be two months.

Outcome(s)

• Primary Outcome: Amount of change in severity and burden of NPIQ delusional items before and after eye training in the group with delusions.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: <= 90age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Sachiko Nakayama
• Source(s) of Monetary Support: Japan Society for the Promotion of Science