Status:
COMPLETED
Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) Patients
Lead Sponsor:
Istanbul Medipol University Hospital
Collaborating Sponsors:
ScandiBio Therapeutics AB
Alanya Alaaddin Keykubat University
Conditions:
Alzheimer Disease
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
In this study, investigators aim to activate mitochondria of brain cell-types in AD and PD patients by increasing the hepatic, plasma and brain levels of pivotal metabolic cofactors via simultaneous d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04044131
Start Date
December 2 2019
End Date
April 20 2021
Last Update
August 8 2022
Active Locations (2)
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1
Alanya Alaaddin Keykubat University Hospital
Antalya, Turkey (Türkiye), 07400
2
Medipol University Hospital
Istanbul, Turkey (Türkiye), 34214