ScandiBio Therapeutics has initiated a Phase II study in patients with Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) using Combined Metabolic Cofactors Supplementation (CMCS) consisting of L-serine, N-acetyl-L-cysteine (NAC), nicotinamide riboside (NR), and L-carnitine tartrate. A total of 60 AD and 60 PD patients will be randomized on a 2:1 basis to the cofactor mixture or placebo at two different centers. The primary objective for AD patients is to assess the clinical differences in cognition of subjects receiving twelve-weeks treatment either with metabolic cofactors supplementation or placebo. The primary analysis will be the difference in cognitive and daily living activity scores between the placebo and the treatment arms, which will be assessed by Mini Mental State Examination (MMSE), Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and Alzheimer’s Disease Cooperative Study – Activities of Daily Living (ADCS-ADL) in AD patients. The primary objective for PD patients is to assess the clinical difference in motor functions between the subjects receiving twelve-weeks treatment either with metabolic cofactors supplementation or placebo. The primary analysis will be the difference in Unified Parkinson’s Disease Rating Scale (UPDRS) scores between the placebo and the treatment arms in PD patients.
