Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients

• Status: Recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This double-blind, randomized, placebo-controlled, investigator-initiated, multi-centre trial aims to establish metabolic improvements in AD and PD subjects by dietary supplementation with cofactors N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside and serine. Concomitant use of pivotal metabolic cofactors via simultaneous dietary supplementation will stimulate to enhance hepatic β-oxidation and this study's hypothesis is that this will result in increased mitochondrial activity in human brain cell-types.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istanbul Medipol University Hospital
• Collaborators: Alanya Alaaddin Keykubat University; KTH Royal Institute of Technology; Sahlgrenska University Hospital, Sweden; ScandiBio Therapeutics AB
• Treatments: Acetylcysteine; Sorbitol; Tetrahydrofolates

Criteria

Inclusion Criteria:

• Men and women diagnosed with Parkinson's Disease (Hoehn Yahr 2-4, age >18 years) or men and women diagnosed with Alzheimer's Disease. Include patients older than 50 years with mild to moderate Alzheimer's disease according to ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale; ADAS≥12) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB; CDR≤2).

• Patients with stable treatments and clinical course

Exclusion Criteria:

• Inability or unwillingness to give written informed consent

• History of stroke, severe brain trauma, toxic drug exposure

• Neurological examination which indicate to Parkinson-Plus syndrome (i.e., pyramidal, cerebellar and autonomic dysfunction findings and gaze paralysis) for PD

• Uncontrolled Type 1 or type 2 diabetes

• Diarrhea (defined as more than 2 stool per day) within 7 days before enrolment

• Chronic kidney disease with an estimated glomerular filtration rate <60 ml/min/1.73m2

• Significant cardiovascular co-morbidity (i.e. heart failure, documented coronary artery disease, valvular heart disease)

• Patients with active bronchial asthma

• Patients with phenylketonuria (contraindicated for NAC)

• Patients with histamine intolerance

• Clinically significant TSH level outside the normal range (0.04-6 mU/L)

• Known allergy for substances used in the study

• Concomitant medication use: Self-administration of dietary supplements such as any vitamins, omega-3 products, or plant stanol/sterol products within 1 month; Use of an antimicrobial agent in the 4 weeks preceding randomization

• Active smokers consuming >10 cigarettes/day

• Alcohol consumption over 192 grams for men and 128 grams for women per week

• Patients considered as inappropriate for this study for any reason (patients unable to undergo MRI study, noncompliance etc.)

• Active participation in another clinical study