Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial

Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial - Efficiency of 5-aminolevulinic acid for amnestic mild cognitive impairment and early Alzheimer disease. Confirmatory randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024911

Enrollment

Registered

2016-11-21

Start date

2016-11-21

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

Amnestic mild cognitive impairment and early Alzheimer disease

Interventions

Daily oral administration of 5-ALA 100mg, each 50mg after breakfast and before bedtime, for 52 weeks. Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Alzheimer disease (NINDCS-ADRDA criteria) 2)MMSE score 20-24 point 3)FAST score 3-4 4)Patients can consent by a document

Exclusion criteria

Exclusion criteria: 1)Severe BPSD(behavioral and psychological symptom of dementia) 2)Severe auditory disorder 3)Poor general condition 4)Complication of adequate pharmaceutical management by patients or caregiver 5)Patients with contraindication of MRI (Magnetic resonance imaging) 6)Patients who cannot join this study

Design outcomes

Primary

Measure	Time frame
The alteration of MMSE (mini mental state examination) and CDR (clinical dementia rating Japan)	—

Secondary

Measure	Time frame
The alteration of WMS-R (Wecheler Memory Scale -reviced)logical memory II and ADAS-Jcog (Alzheimer disease assessment scale-Japan)	—

Countries

Japan

Contacts

Public ContactNoriyuki Matsukawa

Nagoya City University Department of Neurology

norim@med.nagoya-cu.ac.jp052-851-5511

Outcome results

None listed

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