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

Not Applicable

Recruiting

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
G30.1

Registration Number: IRCT20211105052972N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

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

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)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures