The goal of this clinical trial is to learn if orally administered nicotinamide riboside works to slow the progression of early Alzheimer disease in adults. It will also learn about the safety of drug nicotinamide riboside. The main questions it aims to answer are: * Does drug nicotinamide riboside slow the progression of Alzheimer disease as measured by the Clinical Dementia Rating scale. * What medical problems do participants have when taking drug nicotinamide riboside? Researchers will compare drug nicotinamide riboside to a placebo (a look-alike substance that contains no drug) to see if nicotinamide riboside works to treat early Alzheimer disease. Participants will: * Take drug nicotinamide ribosie or a placebo every day for 24 months * Visit the clinic once every 26 weeks for checkups and tests
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
270
Nicotinamide Riboside 1000mg administered two times a day. Given as capsules. Duration of the trial; 104 weeks.
Placebo drug, administered two times a day. Given as capsules. Duration of the trial; 104 weeks.
Haraldsplass Deaconess Hospital
Bergen, Norway
RECRUITINGHaukeland University Hospital
Bergen, Norway
NOT_YET_RECRUITINGDisease severity assessed by the Clinical Dementia Rating scale (CDR) sum of boxes.
CDR is a scale assessing clinical impairment in AD. CDR integrates assessments from 3 domains of cognition (memory, orientation, judgment/problem-solving) and 3 domains of function (community affairs, home/hobbies, personal care). Following semi-structured caregiver interview and systematic participant examination, the rater assigns a score describing the participant's current performance level in each of these domains of life functioning. The "Sum of boxes" scoring methodology (CDR-SB) sums the score for each of the 6 domains and provides a value ranging from 0 to 18 with higher scores indicating greater impairment. Positive change from baseline indicates greater impairment.
Time frame: From baseline to the end of treatment at 104 weeks.
Change from baseline in the MoCA score at Week 104.
MoCA is a validated global measure of cognitive ability. The MoCA scale ranges from 0 - 30. Lower scores indicate cognitive impairment.
Time frame: From baseline to the end of treatment at 104 weeks.
Change from baseline in Amsterdam ADL scale short version (A-IADL-Q-SV) at Week 104.
The Amsterdam ADL scale short version (A-IADL-Q-SV) is a 30-item, proxy-completed, psychometrically validated instrument designed to measure functional decline in instrumental activities of daily living (IADL). Lower scores reflect greater impairment.
Time frame: From baseline to the end of treatment at 104 weeks
Change from baseline in delayed recall performance on the CERAD 10-Word List at Week 104
CERAD 10-Word List Test evaluates memory. Higher scores reflect better performance.
Time frame: From baseline to the end of treatment at 104 weeks.
Change from baseline in executive functioning as measured by Trail-Making Test Part B completion time at Week 104
Trail-Making Test B (TMT-B) measures executive function. Score = Time to Completion. Maximumt time in this trial is 360 sekunds. Longer time reflects greater impairment.
Time frame: From baseline to the end of treatment at 104 weeks.
Change from baseline in verbal fluency as measured by the COWAT (total correct words for F, A, S) at Week 104.
The Controlled Oral Word Association Test (COWAT) F A S version assesses verbal fluency. The total score is simply the count of all valid, non-repeated, rule-adherent words. Higher scores reflect better performance.
Time frame: From baseline to the end of treatment at 104 weeks.
Change from baseline in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at Week 104.
The NPI-Q measures the burden of 12 neuropsychiatric symptoms of dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, and appetite/eating. Symptom severity is rated on a 3-point scale with higher scores indicating worse symptoms. Minimum score would be 0 and maximum score would be 36.
Time frame: From baseline to the end of treatment at 104 weeks.
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