Nicotinamide as an Early Alzheimer's Disease Treatment (NEAT)
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| ClinicalTrials.gov Identifier: NCT03061474 |
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Recruitment Status :
Completed
First Posted : February 23, 2017
Results First Posted : October 17, 2023
Last Update Posted : October 17, 2023
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Sponsor:
University of California, Irvine
Information provided by (Responsible Party):
Joshua Grill, University of California, Irvine
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Conditions |
Alzheimer's Disease Mild Cognitive Impairment |
| Interventions |
Drug: Nicotinamide Drug: Placebo Comparator |
| Enrollment | 46 |
Participant Flow
| Recruitment Details | 46 participants received at least 1 dose of study drug. |
| Pre-assignment Details |
| Arm/Group Title | Nicotinamide | Placebo |
|---|---|---|
 Arm/Group Description |
1500mg twice daily: 2, 750mg tablets taken orally twice daily Nicotinamide: Niacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet. |
1500mg twice daily: 2, 750mg tablets taken orally twice daily Placebo Comparator: Oral Tablet |
| Period Title: Overall Study | ||
| Started | 24 | 22 [1] |
| Completed | 22 | 18 |
| Not Completed | 2 | 4 |
| Reason Not Completed | ||
| Adverse Event | 2 | 0 |
| Safety Risk | 0 | 1 |
| Participant unwilling or unable to participate | 0 | 2 |
| Lost to Follow-up | 0 | 1 |
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[1]
22 participants received treatment therapy.
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Baseline Characteristics
| Arm/Group Title | Nicotinamide | Placebo | Total | |
|---|---|---|---|---|
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Arm/Group Description |
1500mg twice daily: 2, 750mg tablets taken orally twice daily Nicotinamide: Niacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet. |
1500mg twice daily: 2, 750mg tablets taken orally twice daily Placebo Comparator: Oral Tablet |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 24 | 22 | 46 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 24 participants | 22 participants | 46 participants | |
| 74.56 (8.97) | 72.92 (744) | 73.78 (8.23) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | 22 participants | 46 participants | |
| Female |
10 41.7%
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10 45.5%
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20 43.5%
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| Male |
14 58.3%
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12 54.5%
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26 56.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | 22 participants | 46 participants | |
| Hispanic or Latino |
1 4.2%
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1 4.5%
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2 4.3%
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| Not Hispanic or Latino |
23 95.8%
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21 95.5%
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44 95.7%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 24 participants | 22 participants | 46 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
2 8.3%
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1 4.5%
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3 6.5%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
1 4.2%
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0 0.0%
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1 2.2%
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| White |
21 87.5%
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21 95.5%
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42 91.3%
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| More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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| Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 24 participants | 22 participants | 46 participants |
| 24 | 22 | 46 | ||
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Mini-Mental State Examination
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 24 participants | 22 participants | 46 participants | |
| 25.62 (2.87) | 25.5 (3.22) | 25.57 (3.01) | ||
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[1]
Measure Description: The Mini-Mental State Examination is a brief mental status exam and widely used dementia screening instrument. It evaluates orientation to time and place, memory, attention, language, and visuospatial ability. Range: 0-30; a lower score indicates greater impairment.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Dr. Joshua Grill |
| Organization: | University of California, Irvine |
| Phone: | (949) 824-5905 |
| EMail: | jgrill@uci.edu |
Publications:
| Responsible Party: | Joshua Grill, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT03061474 |
| Other Study ID Numbers: |
20163246 |
| First Submitted: | February 13, 2017 |
| First Posted: | February 23, 2017 |
| Results First Submitted: | August 22, 2023 |
| Results First Posted: | October 17, 2023 |
| Last Update Posted: | October 17, 2023 |