Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

What Was Tested

This registered not phased trial tested Cyanocobalamin (Vitamin B12) for parkinson's disease.

This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa.

The researchers are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.

It had two arms (groups): B vitamin regimen (experimental) and No vitamins (no intervention).

No vitamin intervention.

The registry classes the interventions as dietary supplement.

Who Took Part

The registry lists 150 planned participants were the target.

It was open to people of any sex aged from 40 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria. Montreal Cognitive Assessment (MOCA) ≥15. 40-90 years of age. Estimated glomerular filtration rate ≥60. Absence of uncontrolled hypertension in medical history.

The full record lists 8 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Cyanocobalamin (Vitamin B12) group and the comparison group ran side by side rather than switching.

Being open-label, the Cyanocobalamin (Vitamin B12) study did not mask who received what.

It started in 2024-03-05 with completion listed for 2025-12-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hyperhomocysteinemia and B vitamin deficiency (time frame: baseline measurement). Hyperhomocysteinemia and B vitamin deficiency (time frame: baseline measurement). Hyperhomocysteinemia and B vitamin deficiency (time frame: baseline measurement).

It also tracked 2 secondary outcomes, for example Hyperhomocysteinemia and cognitive assessments and Hyperhomocysteinemia and measurement of neurofilament light in plasma.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Cyanocobalamin (Vitamin B12) in 150 people with parkinson's disease.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Parkinson's disease research.