N-DOSE AD: A Dose Optimization Trial of Nicotinamide Riboside in Alzheimer's Disease

What Was Tested

This registered phase 2 trial tested NAD+ for dementia, alzheimer's & cognitive decline.

It had three arms (groups): Placebo (placebo comparator), one (experimental) and one (experimental).

Placebo, no active ingredients. Administered in capsule form twice daily for the duration of the trial (12 weeks).

The registry classes the interventions as dietary supplement and other.

More on the Plan

Individuals with AD (n = 80) will be recruited starting November 2022.

Who Took Part

80 actual participants took part.

It was open to people of any sex aged from 50 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: The following condition must apply to the prospective patient at screening prior to receiving study agent:. Diagnosis of probable Alzheimer Disease (AD) according to the core clinical criteria updated in the National Institute on Aging (NIA) and Alzheimer's Association guidelines. Biomarker evidence consistent with AD neuropathologic change, defined by cerebrospinal fluid (CSF) markers. Diagnosed with AD within two years from enrollment. Clinical Dementia Rating (CDR) 0.5-1 (inclusive) at enrollment.

The full record lists 11 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The dementia, alzheimer's & cognitive decline participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

Groups ran in parallel: each of the dementia, alzheimer's & cognitive decline participants stayed in one arm throughout.

Neither the dementia, alzheimer's & cognitive decline participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-11-22 with completion listed for 2025-06-05.

It ran at 2 sites in Norway (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cerebral NAD levels measured by 31P-MRS (time frame: 12 weeks for primary analysis. 4, 8 and 12 weeks for secondary analysis).

It also tracked 1 secondary outcome, for example CSF NAD or other metabolite of the NAD metabolome, measured by LC-MS.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 80 people with dementia, alzheimer's & cognitive decline.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Dementia, Alzheimer's & cognitive decline research.