Evaluation of Safety and Efficacy of Intranasal Administration of iPS Cell-derived Exosomes in Mild Cognitive Impairment

A Double-Blind Randomized Controlled Trial to Evaluate the Effects of Intranasal Administration of Exosomes on Cognitive Function, Immunosenescence, and Muscle Strength in Middle-Aged and Older Adults

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1033250410

Enrollment

Registered

2025-10-03

Start date

2025-10-03

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Mild Cognitive Impairment (MCI) associated with aging Mild Cognitive Impairment Cognitive decline Age-related cognitive impairment

Interventions

Intranasal administration of iPS cell-derived exosomes. Participants are randomized into three groups: high-dose, low-dose, and placebo. Administration once daily for 4 weeks. Placebo group receives i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 50-80 years, male or female Mild cognitive impairment MMSE score: 24-27, or MoCA-J score: 19-25 Able to attend clinic visits and complete all study assessments Written informed consent obtained from the participant Presence of a caregiver or family member who can assist with intranasal administration, video recording, clinic visits, and provide written consent as a supporter Proficiency in Japanese (Japanese nationality or equivalent, e.g., JLPT N1 or higher)

Exclusion criteria

Exclusion criteria: Overt dementia MMSE <= 23 MoCA-J <= 18 Bleeding tendency, including use of anticoagulants Severe underlying diseases such as bone marrow dysfunction, liver cirrhosis, severe diabetes mellitus, HIV infection, or other viral diseases Immune or hematologic disorders, including autoimmune diseases (rheumatoid arthritis, SLE, Basedow's disease, dermatomyositis), thrombocytopenia, hypersplenism, portal hypertension, autoimmune hemolytic anemia Currently undergoing cancer treatment Use of drugs or supplements affecting cognitive function (including anti-aging supplements such as NMN) Severe allergic diseases of scalp/face, fever, or chronic nasal obstruction Mental or language disorders that make cognitive assessments difficult Considered inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
Change from baseline in MMSE score at 6 weeks Change from baseline in MoCA-J score at 6 weeks	—

Secondary

Measure	Time frame
Grip strength and walking speed Immunological parameters (e.g., lymphocyte count, inflammatory markers) Safety endpoints: nasal endoscopy, adverse events, laboratory findings (liver, renal, CRP, electrolytes) Cognitive function app score (MIRUDAKE)	—

Contacts

Public ContactHiroyuki Matsumura

Tokyo Relife

h_matsumura@tokyo-relife.com+81-3-6264-6761

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026