Phase
Condition
Dementia
Treatment
Placebo
Nicotinamide Riboside dose escalation (up to 3000 mg daily in total)
Nicotinamide Riboside supplementation 1000mg daily in total
Clinical Study ID
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The following condition must apply to the prospective patient at screening prior toreceiving study agent:
Diagnosis of probable Alzheimer Disease (AD) according to the core clinicalcriteria updated in the National Institute on Aging (NIA) and Alzheimer'sAssociation guidelines.
Biomarker evidence consistent with AD neuropathologic change, defined bycerebrospinal fluid (CSF) markers.
Diagnosed with AD within two years from enrollment.
Clinical Dementia Rating (CDR) 0.5-1 (inclusive) at enrollment.
Age 50 to 85 years (inclusive) at the time of enrollment.
A study partner (i.e. a family member or a friend) able to provide study dataand assist the participant in the study drug administration, i.e. contact ≥ 3times weekly.
Capacity to provide written informed consent for study participation defined asMontreal Cognitive Assessment (MoCA) score ≥ 16 or Mini Mental State Evaluation (MMSE) score ≥ 20. MMSE or MoCA must have been performed within 6 months priorto baseline. If there is any doubt regarding the participants capacity to giveinformed consent we will ask for an independent evaluation by a consultantclinician who is not associated with the N-DOSE AD study.
Cholinesterase inhibitors and memantine can be used if stable for 8 weeks priorto baseline visit.
Able to undergo lumbar puncture.
Able to undergo magnetic resonance imaging (MRI)
Exclusion
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Diagnosis of dementia other than probable AD.
Comorbidity that precludes study participation or data interpretation.
Any psychiatric disorder that would interfere with compliance in the study.
Any severe somatic illness that would interfere with compliance and participation inthe study.
Use of high dose vitamin B3 supplementation within 30 days of enrollment.
Metabolic, neoplastic, or other physically or mentally debilitating disorder atbaseline visit.
Current treatment with Oral Anti-coagulation Therapies
Implants that preclude MRI examinations, e.g. DBS, pacemaker
Study Design
Study Description
Connect with a study center
Haraldsplass Deaconess Hospital
Bergen, Vestland 5009
NorwaySite Not Available
Haukeland University Hospital
Bergen, Vestland 5021
NorwaySite Not Available
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