Cognition Disorders in Old AgeNCT04078178
Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment
A study testing Niagen in people with Cognition Disorders in Old Age and Mild Cognitive Impairment, run by Steven E Arnold, MD at 1 site in United States.
Trial summary
In this research study we want to learn more about whether taking Niagen, a daily supplement containing a form of Vitamin B3, will improve cognitive function, mood, and daily activity in people with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition Disorders in Old Age, Mild Cognitive Impairment, Cognitive Decline
- What is being tested?
- Niagen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 60 and up;
- Memory and other cognitive complaints consistent with SCD or MCI as defined by the National Institute on Aging:
- SCD will be defined as: i. any subjective concern of change in cognitive functioning without objective evidence of cognitive impairment, and ii. complete preservation of functional abilities and independence in instrumental activities of daily living.
- MCI will be defined as: i. a preexisting diagnosis of MCI given by a trained physician or behavioral health provider, or ii. evidence of objective impairment in cognitive functioning in one or more domain with preservation of functional abilities and independence in instrumental activities of daily living as defined by the National Institute on Aging;
- Minimum score of 16 on t-MoCA;
- Ability to provide direct informed consent as assessed by obtaining a score of 70% on questions 1-10, and answer 'yes' to questions 11-14 of the Informed Consent Worksheet after two attempts;
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- Education level, English language skills and literacy indicates participant able to complete all assessments;
- Willing and able to complete all assessment and study procedures;
- Not pregnant, lactating, or of child-bearing potential;
- If on cholinesterase inhibitor and/or memantine, doses are stable for 3 months prior to baseline.
Who cannot join
- Any specific CNS disease history other than suspected ADRD, such as major clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological of cognitive deficits or complaints;
- Any impairment in instrumental activities of daily living that would indicate a level of cognitive impairment beyond MCI as assessed by a trained rater;
- Clinically significant unstable medical condition that could affect safety or compliance with the study and would, in the opinion of the investigator, pose a risk to the participant if they were to participate in the study;
- History of neuroimaging with evidence of major infarction, injury, infection, or other focal lesions that may be related to cognitive dysfunction;
- If participating in the optional lumbar puncture sub-study, any contraindication to undergo lumbar punctures, such as:
- abnormal coagulation PT/INR test result, outside of the normal range of 0.9 to 1.2 platelet counts below 50,000 (determined by a licensed study physician or Nurse Practitioner after reading test results).
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- Platelet counts below 50,000.
- Use of Coumadin, Warfarin, or other blood thinner medications.
- Infection near the puncture site, or spinal column deformities (a licensed physician or Nurse Practitioner will examine the site visually for infection or spinal deformities before performing the procedure).
- Known allergy to Lidocaine.
- Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
- Current suicidal ideation or history of suicide attempt;
- History of alcohol or other substance abuse or dependence within the past two years;
- Any significant systemic illness or medical condition that could affect safety or compliance with study;
- Laboratory abnormalities in Vitamin B12, Thyroid Stimulating Hormone (TSH), or other common laboratory parameters that might contribute to cognitive dysfunction or other abnormalities in hematological, hepatic or renal function tests;
- Current use of medications with psychoactive properties that in the opinion of the principal investigator, may be deleteriously affecting cognition (e.g., anticholinergics, antihistamines, antipsychotics, sedative hypnotics, anxiolytics);
- Any known hypersensitivity to nicotinamide riboside, or its principal metabolite, nicotinamide mononucleotide;
- No consumption of dietary supplements containing more than 100mg niacin, nicotinamide riboside (NR), or nicotinamide mononucleotide (NMN) as the primary agents 30 days prior to baseline and for the duration of the trial;
- Use of other investigational agents or interventions one month prior to entry and for the duration of the trial;
- If participating in the optional MR sub-study: Any contraindication to undergo MRI studies, such as history of cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head, prosthetic heart valves, and/or severe claustrophobia impeding ability to participate in an imaging study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alzheimer's Clinical and Translational Research Unit
Charlestown, Massachusetts, 02129
About this study
Official title: A Crossover, Randomized Block Sequence, Double-Blind, Placebo-Controlled Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment in Aging
In this research study we want to learn more about whether taking Niagen, a daily supplement containing a form of Vitamin B3, will improve cognitive function, mood, and daily activity in people with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI).
Read the detailed description
Over a 6 month period, we will ask study participants to take both Niagen or a placebo for 8 weeks each and complete research visits ever 4 or 8 weeks. Most research visits will involve a blood draw, cognitive testing, and mood questionnaires. We will ask you to come to our center 4-5 times to complete some study activities in-person. There will be an option to participate in a lumbar puncture sub-study, in which participants would have up to 3 lumbar punctures. There will also be an option to participate in an MRI sub-study, in which participants would have up to 3 MRIs over the course of the study. In between research visits, we will also ask the participants to wear a Fitbit activity tracker and play computerized brain games a few times a week. This will enable us to get a snapshot of each subject's functioning levels day to day and better determine whether or not the supplement is having an effect on the participant.
- Being tested
- Niagen, Placebo Comparator
- Keywords
- Mild Cognitiive Impairment, Subjective Cognitive Decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiagenDietary supplement
Nicotinamide Riboside
Placebo ComparatorDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Active Niagen, Placebo | Experimental | Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks. Receives: Dietary Supplement: Niagen; Dietary Supplement: Placebo Comparator |
| Sequence 2: Placebo, Active Niagen | Experimental | Subjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks. Receives: Dietary Supplement: Niagen; Dietary Supplement: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
The primary outcome of this study will be objective measures of cognitive performance measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, crossover, and the end of study. RBANS has a mean score of 100 with a standard deviation of 15. Scores range from 40 to 160. Higher scores indicate normal cognition.
Measured: From baseline through end of study at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start30 Oct 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognition Disorders in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were randomized into 2 Treatment sequences, one starting with Placebo followed by Niagen; and the other sequence starting with Active Niagen and followed by Placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven E Arnold, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steven E Arnold, MD, Massachusetts General Hospital
- Investigators
- Steven Arnold, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078178
- Sponsor's protocol ID
- 2019P002668
- Status last verified
- Nov 2024
- First submitted
- 27 Aug 2019
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be DE-Identified
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover, Randomized Block Sequence, Double-Blind, Placebo-Controlled Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment in Aging
- ClinicalTrials.gov ID
- NCT04078178
- Acronym / sponsor ID
- 2019P002668
- Keywords
- Mild Cognitiive Impairment, Subjective Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Steven E Arnold, MDUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this research study we want to learn more about whether taking Niagen, a daily supplement containing a form of Vitamin B3, will improve cognitive function, mood, and daily activity in people with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI).
Detailed description
Over a 6 month period, we will ask study participants to take both Niagen or a placebo for 8 weeks each and complete research visits ever 4 or 8 weeks. Most research visits will involve a blood draw, cognitive testing, and mood questionnaires. We will ask you to come to our center 4-5 times to complete some study activities in-person. There will be an option to participate in a lumbar puncture sub-study, in which participants would have up to 3 lumbar punctures. There will also be an option to participate in an MRI sub-study, in which participants would have up to 3 MRIs over the course of the study. In between research visits, we will also ask the participants to wear a Fitbit activity tracker and play computerized brain games a few times a week. This will enable us to get a snapshot of each subject's functioning levels day to day and better determine whether or not the supplement is having an effect on the participant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized into 2 Treatment sequences, one starting with Placebo followed by Niagen; and the other sequence starting with Active Niagen and followed by Placebo.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Active Niagen, Placebo | Experimental | Dietary Supplement: Niagen, Dietary Supplement: Placebo ComparatorSubjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 1 took Niagen daily for 8 weeks, followed by Placebo daily for 8 weeks. |
| Sequence 2: Placebo, Active Niagen | Experimental | Dietary Supplement: Niagen, Dietary Supplement: Placebo ComparatorSubjects received 1000 mg Niagen and PBO dispensed in randomized blocks. Participants in Sequence 2 took Placebo daily for 8 weeks, followed by Active Niagen daily for 8 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 60 and up;
- Memory and other cognitive complaints consistent with SCD or MCI as defined by the National Institute on Aging:
- Minimum score of 16 on t-MoCA;
- Ability to provide direct informed consent as assessed by obtaining a score of 70% on questions 1-10, and answer 'yes' to questions 11-14 of the Informed Consent Worksheet after two attempts;
- Education level, English language skills and literacy indicates participant able to complete all assessments;
Key exclusion criteria (20 listed)
- Any specific CNS disease history other than suspected ADRD, such as major clinical stroke, brain tumor, normal pressure hydrocephalus, multiple sclerosis, significant head trauma with persistent neurological of cognitive deficits or complaints;
- Any impairment in instrumental activities of daily living that would indicate a level of cognitive impairment beyond MCI as assessed by a trained rater;
- Clinically significant unstable medical condition that could affect safety or compliance with the study and would, in the opinion of the investigator, pose a risk to the participant if they were to participate in the study;
- History of neuroimaging with evidence of major infarction, injury, infection, or other focal lesions that may be related to cognitive dysfunction;
- If participating in the optional lumbar puncture sub-study, any contraindication to undergo lumbar punctures, such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiagenNicotinamide Riboside | Dietary supplement | Sequence 1: Active Niagen, Placebo, Sequence 2: Placebo, Active Niagen |
| Placebo ComparatorPlacebo | Dietary supplement | Sequence 1: Active Niagen, Placebo, Sequence 2: Placebo, Active Niagen |
Primary outcome
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
Time frame: From baseline through end of study at 16 weeks
The primary outcome of this study will be objective measures of cognitive performance measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, crossover, and the end of study. RBANS has a mean score of 100 with a standard deviation of 15. Scores range from 40 to 160. Higher scores indicate normal cognition.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. All data will be DE-Identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Arnold, MD principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niagen in people with Cognition Disorders in Old Age and Mild Cognitive Impairment, run by Steven E Arnold, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of Niagen vs PBO on Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). (time frame: From baseline through end of study at 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.