UMIN-ICDS Clinical Trial

Public title

Changes in patient and caregiver burden after switching lecanemab from intravenous infusion to subcutaneous injection

Acronym

LECAN-SHIFT

Scientific Title

Changes in Patient and Caregiver Burden and Treatment Delivery Following the Switch from Intravenous to Subcutaneous Lecanemab: A Prospective Single-Center Observational Study

Scientific Title:Acronym

LECAN-SHIFT Study

Region

Japan

Condition

Mild cognitive impairment or mild dementia due to Alzheimer's disease.

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate within-patient changes in overall treatment burden from before switching to 8 weeks after starting subcutaneous lecanemab among patients who elect to switch from intravenous treatment in routine care. Caregiver burden, patient and caregiver treatment-related time, satisfaction and preferences, treatment delivery, and treatment continuation or changes at 8 weeks and day 168 will also be assessed or described.

Basic objectives2

Others

Basic objectives -Others

Assessment of patient and caregiver treatment burden and treatment delivery.

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Within-patient change in patient-reported overall treatment burden (Q1, 0 = no burden at all; 10 = extremely burdensome), calculated as the 8-week score minus the pre-switch score. The baseline questionnaire is completed before the first subcutaneous dose, preferably within 14 days and no earlier than 28 days before it. The follow-up questionnaire is completed 56 days after the first subcutaneous dose (allowable window: days 49-63). At both assessments, Q1 refers to all lecanemab treatment during the 28 days ending the day before questionnaire completion. Negative changes indicate reduced burden. The 8-week assessment is obtained after interruption, return to intravenous treatment, or lecanemab discontinuation whenever consent and the ability to self-report are maintained.

Key secondary outcomes

Key secondary outcomes: (1) change in caregiver-reported overall burden (Q1, 0-10) from baseline to 8 weeks; (2) change in patient administration-related time (minutes per 28 days); (3) change in total caregiver time spent on treatment (minutes per 28 days); and (4) treatment status and reasons at 8 weeks. Time comparisons use the 28 days ending the day before each questionnaire. Additional outcomes include burden components, satisfaction, effects on daily life, preferences, global change, ease of subcutaneous administration, confidence, pain, anxiety, administration difficulties, consultations, work loss, prospectively measured staff time and facility occupancy, patient-caregiver associations, and free-text responses. Time during the initiation period (first subcutaneous dose through day 27) is described separately. Treatment status at day 168 is assessed using routine medical records only, without additional questionnaires, visits, or research telephone calls.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients: (1) Age 18 years or older. (2) Receiving intravenous lecanemab in routine care for mild cognitive impairment or mild dementia due to Alzheimer's disease. (3) A clinical decision to switch to subcutaneous treatment, independent of study participation, documented before study explanation. (4) Normally at least three intravenous doses before the first subcutaneous dose. Patients with fewer doses may participate in burden assessment, with dose count, treatment duration and reason recorded; this does not relax Japanese prescribing requirements. (5) Able to complete baseline questionnaires before the first subcutaneous dose, preferably within 14 days and at most 28 days beforehand. (6) Able to understand the study and provide voluntary written consent. (7) Able to express their own Q1 response; neutral reading, enlarged text or writing assistance is allowed, but inferred proxy responses are not. Caregivers: age 18 years or older; a family member or primary unpaid caregiver nominated by an enrolled patient and involved in treatment, visits or daily support; expected to be the same respondent at both assessments; able to understand the study and provide written consent.

Key exclusion criteria

Patients: (1) Study participation is judged to have influenced the switching decision or its timing. (2) Unable to give their own Q1 response despite reasonable support. (3) Excessive burden from study explanation or questionnaires. (4) Participation in another burden or satisfaction study, or similar circumstances, is expected to substantially affect assessment. (5) Otherwise judged unsuitable by the principal investigator, with the reason recorded. Caregivers: (1) No substantive involvement in treatment support, preventing assessment of pre-switch burden. (2) Paid professionals providing care solely as part of their work. (3) Excessive burden from explanation or questionnaires. (4) Otherwise judged unsuitable by the principal investigator, with the reason recorded.

Target sample size

60

Name of lead principal investigator

1st name	Kazumasa
Middle name
Last name	Oura

Organization

Morioka Oura Neurology clinic

Division name

Neurology

Zip code

020-0133

Address

3-27-5 Aoyama, Morioka, Iwate 020-0133, Japan

TEL

019-613-8007

Email

kazu.ohura@gmail.com

Name of contact person

1st name	Kazumasa
Middle name
Last name	Oura

Organization

Morioka Oura Neurology clinic

Division name

Neurology

Zip code

020-0133

Address

3-27-5 Aoyama, Morioka, Iwate 020-0133, Japan

TEL

019-613-8007

Homepage URL

Email

kazu.ohura@gmail.com

Institute

Morioka Oura Neurology clinic

Institute

Department

Personal name

Organization

Morioka Oura Neurology clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Ethics Committee of the Medical and Health Resources Research Institute (MHRRI)

Address

Room 204, 2-17-18 Takada, Toshima-ku, Tokyo 171-0033, Japan

Tel

03-5904-8534

Email

kojima@mhrri.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

盛岡おおうら脳神経内科クリニック（岩手県）

Date of disclosure of the study information

2026

Year

11

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

No plan to share individual participant data externally. Results will be reported in aggregate without identifying individuals.

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

18

Day

Date of IRB

2026

Year

10

Month

14

Day

Anticipated trial start date

2026

Year

11

Month

13

Day

Last follow-up date

2029

Year

03

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This prospective single-center observational study consecutively enrolls eligible patients whose switch from intravenous to subcutaneous lecanemab has been decided in routine care. The target is 30 patients and up to 30 independently consenting caregivers (maximum total 60). Route, dose, interval, location and administrator are not assigned by the study; no additional tests, blood sampling or imaging are required. Questionnaires are completed before the first subcutaneous dose (within 28 days, preferably 14 days) and at 8 weeks (day 56; window days 49-63), supplemented by clinical and administration/time records. Q1 assesses all treatment during the preceding 28 days and remains applicable after return to intravenous treatment or discontinuation if consent and self-report capacity persist. Patients provide renewed consent before the 8-week questionnaire. Day-168 treatment status is assessed from routine records only. The primary analysis includes patients who start subcutaneous treatment and have paired Q1 responses within the allowed windows. Two-sided Wilcoxon signed-rank testing, change scores, Hodges-Lehmann estimates, 95% confidence intervals and effect sizes are reported alongside treatment status, reasons for change and missingness. Prespecified missing-data sensitivity analyses are performed. Funding is internal to the clinic.

Registered date

2026

Year

11

Month

12

Day

Last modified on

2026

Year

11

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072789