Alzheimer's DiseasePhase 2NEATNCT03061474
Nicotinamide as an Early Alzheimer's Disease Treatment
A Phase 2 study testing Nicotinamide in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University of California, Irvine at 2 sites in United States.
Trial summary
The purpose of this research study is to test whether nicotinamide, also known as vitamin B3 or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild Alzheimer's disease (AD) dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment
- What is being tested?
- Nicotinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2017to 30 Aug 2022
- Phase
- Phase 2
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild Cognitive Impairment (MCI) or dementia due to Alzheimer's disease (AD)
- Biomarker criteria:
- Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 600 pg/mL, or A ratio of total tau to Aβ42 ≥ 0.39.
- Mini-Mental State Exam (MMSE) ≥ 20
- Blood laboratories, urinalysis, and electrocardiogram are within normal limits or deemed clinically not significant by the site investigator
- Stable medications (including approved AD therapies) for at least 4 weeks
Show all 10Show fewer
- At least 6 years of education
- Able to swallow oral tablets
- Speaks English fluently
- Available qualified study partner (≥3 times per week in-person communication with the participant)
Who cannot join
- Active neurological or psychiatric diagnosis other than AD that may affect cognition and/or function. (Obstructive sleep apnea is permitted, if treated.)
- Inability to undergo lumbar puncture, including use of Coumadin, novel oral anticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily is permitted.
- Hachinski ischemic scale > 4
- Magnetic Resonance Imaging (MRI) incompatibility
- MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter hyperintensity (Cardiovascular Health Study score 7-8+)
- Diagnosis of cancer in the previous 5 years (with the exception of basal or squamous cell carcinoma)
Show all 14Show fewer
- Geriatric Depression Scale (GDS) score >6
- History within the past 5 years of alcohol or substance use disorder
- Laboratory evidence of a clinically significant abnormality that may interfere with study assessments
- Active partial or total malabsorptive disease (e.g., celiac disease)
- Resides in a skilled nursing facility
- Participation in a clinical trial of a potential disease-modifying therapy for AD in previous 6-months (time between last investigational drug administration and baseline for the current study)
- Pregnant, lactating or of child bearing potential (that is, women must be 2 years post-menopausal or surgically sterile to be considered not child bearing potential).
- Unwillingness to abstain from over-the-counter nicotinamide for the duration of the trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Irvine
Irvine, California, 92697
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia
The purpose of this research study is to test whether nicotinamide, also known as vitamin B3 or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild Alzheimer's disease (AD) dementia.
Read the detailed description
Nicotinamide, the amide of nicotinic acid (vitamin B3/niacin), is an oral therapy with a wealth of clinical data in a variety of therapeutic areas, including preliminary data supporting its safety in Alzheimer's disease (AD). Preclinical work in a mouse model that develops both plaques and tangles supports the hypothesis that nicotinamide can act as a histone deacetylase (HDAC) inhibitor to reduce phosphorylation of tau.
The study will implement a group sequential design, incorporating a futility analysis with a go/no-go decision conditional on cerebral spinal fluid CSF biomarker outcomes at 12-months. The primary outcome for the trial is change in p-tau231.
This study timeline includes a screening phase of up to 60 days and treatment phase which is expected to last about 48 weeks and will include 4 study visits.
An additional 12-month treatment and follow-up period is planned, contingent upon a "go" decision based on the primary outcome (CSF p-tau231) or one planned secondary outcome (CSF p-tau181)
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Being tested
- Nicotinamide, Placebo Comparator
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease, Nicotinamide, Niacinamide, Niacin, Nicotinic Acids, Vitamin, Neurodegenerative Diseases, Tauopathies, Dementia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurodegenerative Diseases, Tauopathies, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NicotinamideDrug
Also called Niacinamide
Niacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet.
Placebo ComparatorDrug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Nicotinamide | Experimental | 1500mg twice daily: 2, 750mg tablets taken orally twice daily Receives: Drug: Nicotinamide |
| Placebo | Placebo comparator | 1500mg twice daily: 2, 750mg tablets taken orally twice daily Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in P-tau 231
Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Higher phosphorylated tau (p-tau) is associated with a severity of Alzheimer's disease pathology.
Measured: Baseline to 48 weeks
Vital Signs - Weight
Weight in kg was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Measured: Screening through end of study (week 48)
Vital Signs - BMI
Body Mass Index (BMI) was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Measured: Screening through end of study (week 48)
Vital Signs - Systolic Blood Pressure
Systolic blood pressure was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Measured: Screening through end of study (week 48)
Vital Signs - Diastolic Blood Pressure
Diastolic blood pressure was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Measured: Screening through end of study (week 48)
Vital Signs - Pulse
Pulse rate was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Measured: Screening through end of study (week 48)
Count of Treatment Emergent Adverse Events
Count of treatment emergent adverse events (TEAEs) over the duration of the study period (baseline to 48 weeks).
Measured: Baseline to 48 weeks
Count of Adverse Events by Severity
Count of treatment emergent adverse events (TEAEs) over the duration of the study period (baseline to 48 weeks).
Measured: Baseline to 48 weeks
Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the corresponding assessment period. The scale includes suggested questions to elicit the type of information needed to determine if a suicide-related thought or behavior occurred. The number and proportion of subjects with treatment emergent Suicidal ideation or behavior during the study period of (baseline to week 48) will be reported overall and by study arm. Treatment emergent suicidal ideation or behavior is defined as a "yes" answer at any time during treatment to any one of the questions in the ten suicidal ideation and behavior categories (Categories 1- 10) on the C-SSRS. Self-injurious behavior without suicidal intent, while assessed on the C-SSRS, does not form part of this outcome.
Measured: Baseline to 48 weeks
ECG Abnormalities
Count of participants experiencing at least one electrocardiogram (ECG) abnormality.
Measured: Baseline to 48 weeks
QTC Abnormalities
Count of participants experiencing at least one electrocardiogram (ECG) QT interval abnormality. Abnormal defined as above 460 for men and above 470 for women.
Measured: Baseline to 48 weeks
Change in QTC
Average within-subject change in electrocardiogram QT interval.
Measured: Baseline to 48 weeks
Secondary outcomes (9)
Change in ab40
Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Lower ab40 is associated with a greater probability of fibrillar amyloid burden in the brain.
Measured: Baseline to 48 weeks
Change in ab42
Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Lower ab42 is associated with a greater probability of fibrillar amyloid burden in the brain.
Measured: Baseline to 48 weeks
Change in P-tau 181
Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Higher total value is associated with greater severity of Alzheimer's disease pathology.
Measured: Baseline to 48 weeks
Change in Total Tau
Change in CSF total tau in individuals with mild Alzheimer's disease (AD) dementia or Mild Cognitive Impairment due to AD.
Measured: Baseline to 48 weeks
Change in Ratio of Total Tau/ab40
Change in ratio of key peptides in cerebrospinal fluid (CSF) from baseline to 48 weeks. A lower ab40/tau ratio is associated with a higher risk of dementia.
Measured: Baseline to 48 weeks
Change in Ratio of Total Tau/ab42
Change in ratio of key peptides in cerebrospinal fluid (CSF) from baseline to 48 weeks. A lower ab42/tau ratio is associated with a higher risk of dementia.
Measured: Baseline to 48 weeks
ADASCog-13
ADAS-Cog13 is a structured scale that evaluates memory (immediate and delayed word recall; immediate word recognition), receptive and expressive language, orientation, ideational praxis (preparing a letter for mailing), constructional praxis (copying figures), and attention (number cancellation). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions also are obtained. Range: 0-85; higher scores indicate greater impairment.
Measured: Baseline to 48 weeks
Activities of Daily Living - Mild Cognitive Impairment
The ADCS-ADL-MCI is a measure of patient functional performance in Alzheimer's Disease and Mild Cognitive Impairment trials. The informant-based questionnaire assesses conduct of basic and instrumental Activities of Daily Living (ADLs). A total of 24 ADLs are evaluated. Scores range from 0 to 53, with higher scores representing more maintained function.
Measured: Baseline to 48 weeks
CDR Sum of Boxes
CDR-SB is a composite rating of cognition and everyday function which incorporates both informant input and direct assessment of performance. It assesses through semi-structured interview three cognitive domains (memory, orientation, and judgement/problem solving) and three everyday functional domains (community affairs, home and hobbies, personal care). Level of impairment in each of the six domains is rated from none (score=0) to severe (score=3). The six domain scores are then summed to create the CDR-SB. Range 0-18; higher scores indicate greater impairment.
Measured: Baseline to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start12 Jul 2017
- Primary completion30 Aug 2022
- Study completion30 Aug 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Grill, University of California, Irvine
- Investigators
- Joshua Grill, Ph.D., Principal investigator, Associate Professor of Psychiatry and Human Behavior
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061474
- Sponsor's protocol ID
- 20163246
- Acronym
- NEAT
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2017
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines. DATA Sharing: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Us Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.
Publications
Green KN, Steffan JS, Martinez-Coria H, Sun X, Schreiber SS, Thompson LM, LaFerla FM. Nicotinamide restores cognition in Alzheimer's disease transgenic mice via a mechanism involving sirtuin inhibition and selective reduction of Thr231-phosphotau. J Neurosci. 2008 Nov 5;28(45):11500-10. doi: 10.1523/JNEUROSCI.3203-08.2008.
PubMed 18987186Liu D, Pitta M, Jiang H, Lee JH, Zhang G, Chen X, Kawamoto EM, Mattson MP. Nicotinamide forestalls pathology and cognitive decline in Alzheimer mice: evidence for improved neuronal bioenergetics and autophagy procession. Neurobiol Aging. 2013 Jun;34(6):1564-80. doi: 10.1016/j.neurobiolaging.2012.11.020. Epub 2012 Dec 25.
PubMed 23273573Ketron GL, Grun F, Grill JD, Feldman HH, Rissman RA, Brewer GJ. Pharmacokinetic and pharmacodynamic assessment of oral nicotinamide in the NEAT clinical trial for early Alzheimer's disease. Alzheimers Res Ther. 2025 Mar 11;17(1):59. doi: 10.1186/s13195-025-01693-y.
PubMed 40069789Grill JD, Tam S, Thai G, Vides B, Pierce AL, Green K, Gillen DL, Teng E, Kremen S, Beigi M, Rissman RA, Leger GC, Balasubramanian A, Revta C, Morrison R, Jennings R, Pa J, Zhang J, Jin S, Messer K, Feldman HH. Phase 2A Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Nicotinamide in Early Alzheimer Disease. Neurology. 2025 Jan 14;104(1):e210152. doi: 10.1212/WNL.0000000000210152. Epub 2024 Dec 13.
PubMed 39671543
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind-Randomized, Placebo-Controlled Adaptive Design Trial of Nicotinamide in Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT03061474
- Acronym / sponsor ID
- NEAT / 20163246
- Conditions
- Alzheimer's Disease, Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer's Disease, Nicotinamide, Niacinamide, Niacin, Nicotinic Acids, Vitamin, Neurodegenerative Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 17 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test whether nicotinamide, also known as vitamin B3 or niacinamide, taken in high doses, can reduce phosphorylation of tau (the protein that accumulates in neurofibrillary tangles) in people with Mild Cognitive Impairment or mild Alzheimer's disease (AD) dementia.
Detailed description
Nicotinamide, the amide of nicotinic acid (vitamin B3/niacin), is an oral therapy with a wealth of clinical data in a variety of therapeutic areas, including preliminary data supporting its safety in Alzheimer's disease (AD). Preclinical work in a mouse model that develops both plaques and tangles supports the hypothesis that nicotinamide can act as a histone deacetylase (HDAC) inhibitor to reduce phosphorylation of tau.
The study will implement a group sequential design, incorporating a futility analysis with a go/no-go decision conditional on cerebral spinal fluid CSF biomarker outcomes at 12-months. The primary outcome for the trial is change in p-tau231.
This study timeline includes a screening phase of up to 60 days and treatment phase which is expected to last about 48 weeks and will include 4 study visits.
An additional 12-month treatment and follow-up period is planned, contingent upon a "go" decision based on the primary outcome (CSF p-tau231) or one planned secondary outcome (CSF p-tau181)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinamide | Experimental | Drug: Nicotinamide1500mg twice daily: 2, 750mg tablets taken orally twice daily |
| Placebo | Placebo comparator | Drug: Placebo Comparator1500mg twice daily: 2, 750mg tablets taken orally twice daily |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Mild Cognitive Impairment (MCI) or dementia due to Alzheimer's disease (AD)
- Biomarker criteria:
- Cerebral Spinal Fluid (CSF) Amyloid Beta 1-42 (Aβ42) <= 600 pg/mL, or A ratio of total tau to Aβ42 ≥ 0.39.
- Mini-Mental State Exam (MMSE) ≥ 20
- Blood laboratories, urinalysis, and electrocardiogram are within normal limits or deemed clinically not significant by the site investigator
Key exclusion criteria (14 listed)
- Active neurological or psychiatric diagnosis other than AD that may affect cognition and/or function. (Obstructive sleep apnea is permitted, if treated.)
- Inability to undergo lumbar puncture, including use of Coumadin, novel oral anticoagulants, clopidogrel, or dipyridamole. Use of aspirin <= 325mg daily is permitted.
- Hachinski ischemic scale > 4
- Magnetic Resonance Imaging (MRI) incompatibility
- MRI evidence of cortical stroke >1cm, superficial siderosis, or extensive white matter hyperintensity (Cardiovascular Health Study score 7-8+)
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 |
|---|---|---|
| NicotinamideAlso: NiacinamideNiacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet. | Drug | Nicotinamide |
| Placebo ComparatorOral Tablet | Drug | Placebo |
Primary outcome
Change in P-tau 231
Time frame: Baseline to 48 weeks
Change in key peptide in cerebrospinal fluid (CSF) from baseline to 48 weeks. Higher phosphorylated tau (p-tau) is associated with a severity of Alzheimer's disease pathology.
Vital Signs - Weight
Time frame: Screening through end of study (week 48)
Weight in kg was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Vital Signs - BMI
Time frame: Screening through end of study (week 48)
Body Mass Index (BMI) was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Vital Signs - Systolic Blood Pressure
Time frame: Screening through end of study (week 48)
Systolic blood pressure was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Vital Signs - Diastolic Blood Pressure
Time frame: Screening through end of study (week 48)
Diastolic blood pressure was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Vital Signs - Pulse
Time frame: Screening through end of study (week 48)
Pulse rate was recorded at every study visit (screening, baseline, week 12, week 24, and week 48)
Count of Treatment Emergent Adverse Events
Time frame: Baseline to 48 weeks
Count of treatment emergent adverse events (TEAEs) over the duration of the study period (baseline to 48 weeks).
Count of Adverse Events by Severity
Time frame: Baseline to 48 weeks
Count of treatment emergent adverse events (TEAEs) over the duration of the study period (baseline to 48 weeks).
Columbia-Suicide Severity Rating Scale
Time frame: Baseline to 48 weeks
The Columbia-Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the corresponding assessment period. The scale includes suggested questions to elicit the type of information needed to determine if a suicide-related thought or behavior occurred. The number and proportion of subjects with treatment emergent Suicidal ideation or behavior during the study period of (baseline to week 48) will be reported overall and by study arm. Treatment emergent suicidal ideation or behavior is defined as a "yes" answer at any time during treatment to any one of the questions in the ten suicidal ideation and behavior categories (Categories 1- 10) on the C-SSRS. Self-injurious behavior without suicidal intent, while assessed on the C-SSRS, does not form part of this outcome.
ECG Abnormalities
Time frame: Baseline to 48 weeks
Count of participants experiencing at least one electrocardiogram (ECG) abnormality.
QTC Abnormalities
Time frame: Baseline to 48 weeks
Count of participants experiencing at least one electrocardiogram (ECG) QT interval abnormality. Abnormal defined as above 460 for men and above 470 for women.
Change in QTC
Time frame: Baseline to 48 weeks
Average within-subject change in electrocardiogram QT interval.
9 secondary outcomes
Change in ab40
Time frame: Baseline to 48 weeks
Change in ab42
Time frame: Baseline to 48 weeks
Change in P-tau 181
Time frame: Baseline to 48 weeks
Change in Total Tau
Time frame: Baseline to 48 weeks
Change in Ratio of Total Tau/ab40
Time frame: Baseline to 48 weeks
Change in Ratio of Total Tau/ab42
Time frame: Baseline to 48 weeks
ADASCog-13
Time frame: Baseline to 48 weeks
Activities of Daily Living - Mild Cognitive Impairment
Time frame: Baseline to 48 weeks
CDR Sum of Boxes
Time frame: Baseline to 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18987186Green KN, Steffan JS, Martinez-Coria H, Sun X, Schreiber SS, Thompson LM, LaFerla FM. Nicotinamide restores cognition in Alzheimer's disease transgenic mice via a mechanism involving sirtuin inhibition and selective reduction of Thr231-phosphotau. J Neurosci. 2008 Nov 5;28(45):11500-10. doi: 10.1523/JNEUROSCI.3203-08.2008.
- Background: PubMed 23273573Liu D, Pitta M, Jiang H, Lee JH, Zhang G, Chen X, Kawamoto EM, Mattson MP. Nicotinamide forestalls pathology and cognitive decline in Alzheimer mice: evidence for improved neuronal bioenergetics and autophagy procession. Neurobiol Aging. 2013 Jun;34(6):1564-80. doi: 10.1016/j.neurobiolaging.2012.11.020. Epub 2012 Dec 25.
- Derived from this study: PubMed 40069789Ketron GL, Grun F, Grill JD, Feldman HH, Rissman RA, Brewer GJ. Pharmacokinetic and pharmacodynamic assessment of oral nicotinamide in the NEAT clinical trial for early Alzheimer's disease. Alzheimers Res Ther. 2025 Mar 11;17(1):59. doi: 10.1186/s13195-025-01693-y.
- Derived from this study: PubMed 39671543Grill JD, Tam S, Thai G, Vides B, Pierce AL, Green K, Gillen DL, Teng E, Kremen S, Beigi M, Rissman RA, Leger GC, Balasubramanian A, Revta C, Morrison R, Jennings R, Pa J, Zhang J, Jin S, Messer K, Feldman HH. Phase 2A Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Nicotinamide in Early Alzheimer Disease. Neurology. 2025 Jan 14;104(1):e210152. doi: 10.1212/WNL.0000000000210152. Epub 2024 Dec 13.
- Individual participant dataSharing planned: Yes. Data sharing is integral to the ADCS's mission to develop and execute innovative clinical trials focused on interventions that may prevent, delay, or treat the expression of Alzheimer's disease and related dementias. The ADCS is committed to sharing resources and tools, including data, biospecimens, trial designs, outcome and analysis measures following NIH guidelines. DATA Sharing: The ADCS Data and Sample Sharing Committee (DSSC) grants access to de-identified data to individuals who complete the request process and agree to the conditions in an ADCS/UCSD Data Us Agreement (DUA). After approval and receipt of the fully executed DUA, applicants are authorized to acquire data. Non-compliance with the DUA, including the requirement to provide requested updates will jeopardize further access to data.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Joshua Grill, Ph.D. principal investigator
Associate Professor of Psychiatry and Human Behavior
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide in people with Alzheimer's Disease and Mild Cognitive Impairment, run by University of California, Irvine at 2 sites 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 14 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 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2023). 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?
Change in P-tau 231 (time frame: Baseline to 48 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03061474, which also lists 4 linked publications.
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 17 Oct 2023.