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Assessment the Efficacy of Acetyl-L-carnitine in Patient With Alzheimer's Disease
Plain-language guide to NCT02955706: phase 4 randomized trial of L-Carnitine, 265 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02955706
- Phase
- phase 4
- Status
- completed
- Start
- 2016-04-01
- Completion (planned or actual)
- 2018-09-29
- Participants
- 265 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Alzheimer Disease
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around L-Carnitine.
It had two arms (groups): Active (experimental) and placebo (placebo comparator).
Acetyl-L-carnitine (DongA ST).
Placebo of Acetyl-L-carnitine (DongA ST).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 265 actual participants took part.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: More than 50 Years. Probable Alzheimer disease according to DSM-IV and NINCDS-ADRDA standard. Be able to perform examinations. Be able to visit to hospital with caregiver.
The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: possible or probable or definite vascular dementia according to ninds-airen standard; CNS disease(Cerebrovascular diseases, Epilepsy etc) to cause dementia; patient taking galantamine, memantine, rivastigmine within three months.
How the Study Was Run
Design: randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.
The L-Carnitine group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider and investigator.
It started in 2016-04-01 with completion listed for 2018-09-29.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: ADAS-cog (time frame: 24week).
It also tracked 1 secondary outcome, for example K-MMSE.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of L-Carnitine in 265 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
Our Notes on the Compound
L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.