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Cobalamin impact in reducing the psychotic symptoms of Alzheimer's patients

Investigate the effect of Cobalamin on (CD68) monocytes expressing in Alzheimer's disease patients with psychotic symptoms.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016092125067N3
Enrollment
40
Registered
2016-10-09
Start date
2016-06-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Alzheimer. Alzheimer disease

Interventions

Intervention 1: The First Group: Patients are treated with quetiapine , 12.5 mg in night and rise to 25 to 50 mg according to patient condition.another group received placebo. Intervention 2: The Sec
Placebo
Treatment - Drugs
The First Group: Patients are treated with quetiapine , 12.5 mg in night and rise to 25 to 50 mg according to patient condition.another group received placebo.
The Second Group: Patients are treated with risperidone alone, 0.5 mgr in night and rise to 1 to 2 mg daily according to patient condition combined with a cobalamin 500 mg daily.
The Third Group: Patients received risperidone combined with a cobalamin 500 mg daily, another group received placebo.
The fourth Group:Patients are treated with quetiapine, 12.5 mg in night and rise to 25 to 50 mg according to patient condition with a cobalamin 500 mg daily,.

Sponsors

Rafsanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
64 Years to 84 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria In this study is: (Alzheimer diagnosis in elderly patients is carried out on basis of clinical interviews; DSM IV diagnosis criteria; medical history; clinical examinations; MRI and brain CT scan results and the mini mental state examination score; Patients who have mini mental score above than are studied; patient with Brief Psychiatric Rating Scale score 30-70) Exclusion criteria (Patients who were taking anti-psychotic medication; has schizophrenia symptoms; preliminary psychotic disorders; delirium; psychoses followed by drug or medication take; Other medical background disorders like B12 deficiency and hypothyroidism; Patients needed to be hospitalized; Patients posed to suicide commitment risk; Other causes of dementia like brain tumors; strokes; normal pressure hydrocephalus; Underlying medical conditions; that may cause behavioral or psychotic symptoms or delirium such as infection, medications with anticholinergic effects; corticosteroid use; or neurological insults is the first step in the decision-making process for treatment. In addition, the patients were discarded from the procedure if they need further medical intervention and other drugs according to their health status or families’ remark.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: 2week,4week,8week. Method of measurement: Visual Analogue Scale For Pain Questionnaire.

Secondary

MeasureTime frame
Psychiatric symptoms. Timepoint: Before treatment , 2 weeks and 8 weeks after treatment. Method of measurement: Brief Psychiatric Rating Scale Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Kazemi Arababadi

Rafsanjan University of Medical Sciences

kazemi24@yahoo.com+98 34 3425 8497

Outcome results

None listed

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