Effects of tolerable high dose of Vitamin B12, B6 & Folate intake on Behavioral and psychological symptoms & Quality of life in patients with Alzheimer's disease

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211105052972N1

Enrollment

Registered

2021-12-04

Start date

2021-12-21

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

Alzheimer’s disease with late onset: Onset usually after the age of 65. Alzheimer’s disease with late onset: Onset usually after the age of 65

Interventions

Intervention 1: Intervention group (n=30): each patient takes 3 tablets daily from their caregivers ( 40 mg Tablet of Vitamin B6, 1mg tablet of Vitamin B9, and 1mg tablet of Vitamin B12) after the

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: Alzheimer’s type dementia (DSM-IV, mild and moderate MMSE score=12-24, Age =65) no mentioned past medical history of cardiovascular disease (heart attack, arrhythmia, any heart surgery, and PCI implantation), severe renal disease (Cl Cr. >30 ml/min), seizure, anemia or vitamin B deficiency, and diabetes mellitus ( FBS<126 mg/dl). the patient should not have any recorded family history of cardiovascular disease, Parkinson's disease, or any other psychological or neurological disorder. The patient recording must be free of alcohol or any substance abuse and vitamin B interactive drugs at least one month before starting the trial. each Patient should have a certain caregiver (a Nurse - a family member).

Exclusion criteria

Exclusion criteria: Patients are excluded if they miss the interventions for more than 7 days. death by natural causes. voluntary exclusion. patients with reported severe side effects of vitamin B during the trial. ( vitamin B6 neurotoxicity, arrhythmia, ataxia, nausea, diarrhea, skin rash, abdominal discomfort, drowsiness seizure, and severe depression)

Design outcomes

Primary

Measure	Time frame
Cognitive symptoms. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: MMSE score (Questionnaire) and MoCA test (Questionnaire)/.;BPSD(Behavioral and psychological symptoms of dementia). Timepoint: before intervention and 8 weeks after intervention. Method of measurement: NPI test(Questionnaire).;Quality of life. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: QOL-AD test (Questionnaire).	—

Measure

Time frame

Cognitive symptoms. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: MMSE score (Questionnaire) and MoCA test (Questionnaire)/.;BPSD(Behavioral and psychological symptoms of dementia). Timepoint: before intervention and 8 weeks after intervention. Method of measurement: NPI test(Questionnaire).;Quality of life. Timepoint: before intervention and 8 weeks after intervention. Method of measurement: QOL-AD test (Questionnaire).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Nemati

Mashhad University of Medical Sciences

NematyM@mums.ac.ir+98 51 3800 2361

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026