Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?

What Was Tested

The trial (phase 4) is built around Cyanocobalamin (Vitamin B12).

Background: Vitamin B12 and folate are essential to brain health.

The registry classes the interventions as dietary supplement.

More on the Plan

The primary outcome is Mattis dementia rating scale.

The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia.

These measurements will be performed at baseline and every six months for 24 months.

Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.

Who Took Part

The registry lists 166 planned participants were the target.

It was open to people of any sex aged from 60 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Dementia of Alzheimer's or vascular type. Early dementia defined by Clinical Dementia Rating of 1.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: lives alone.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Cyanocobalamin (Vitamin B12) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

It started in 2004-10 with completion listed for 2008-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: dementia rating scale (time frame: at 6 months, 12 months and 18 months). depression rating scale (time frame: at 6 months, 12 months and 18 months).

It also tracked 3 secondary outcomes, for example vitamin b12, folate and homocysteine.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Cyanocobalamin (Vitamin B12) in 166 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.