Trial Outcomes & Findings for Effect of Blueberry Supplementation on Alzheimer's Biomarkers (NCT NCT05172128)

NCT ID: NCT05172128

Last Updated: 2024-09-19

Results Overview

Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Single Arm Blueberry Supplementation single arm blueberry supplementation
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Blueberry Supplementation on Alzheimer's Biomarkers

Baseline characteristics by cohort

Measure	Single Arm Blueberry Supplementation n=10 Participants single arm blueberry supplementation
Age, Continuous	80.20 years STANDARD_DEVIATION 5.16 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants
Education	18.10 years STANDARD_DEVIATION 2.15 • n=5 Participants
Mini-Mental State Examination (MMSE)	27.20 units on a scale STANDARD_DEVIATION 2.15 • n=5 Participants
Weschler Logical Memory Delay	4.80 units on a scale STANDARD_DEVIATION 3.43 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in NfL level from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

Outcome measures

Measure	Blueberry Supplementation n=10 Participants All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay Baseline	30.09 pg/mL Standard Error 4.64
Change in Blood Neurofilament Light (NfL) Levels as Measured by Blood Biomarker Assay 12 weeks	44.25 pg/mL Standard Error 16.85

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in blood glial fibrillary acidic protein (GFAP) levels from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

Outcome measures

Measure	Blueberry Supplementation n=10 Participants All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay Baseline	239.86 pg/mL Standard Error 31.15
Change in Blood Glial Fibrillary Acidic Protein (GFAP) Levels as Measured by Blood Biomarker Assay 12 weeks	234.27 pg/mL Standard Error 26.98

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in blood Amyloid beta 42/40 ratio (Aβ42 divided by Aβ40) from baseline to 12 weeks as measured by blood biomarker assay. Lower ratios increase likelihood of AD pathology.

Outcome measures

Measure	Blueberry Supplementation n=10 Participants All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay Baseline	.050 ratio Standard Error .002
Change in Blood Amyloid Beta 42/40 as Measured by Blood Biomarker Assay 12 weeks	.050 ratio Standard Error .002

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in p-tau 181 from baseline to 12 weeks as measured by blood biomarker assay in pg/mL

Outcome measures

Measure	Blueberry Supplementation n=10 Participants All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Change in P-tau 181 as Measured by Blood Biomarker Assay Baseline	37.24 pg/mL Standard Error 3.31
Change in P-tau 181 as Measured by Blood Biomarker Assay 12 weeks	38.04 pg/mL Standard Error 2.58

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Data not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: Data not collected.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Change in brain-derived neurotrophic factor (BDNF) from baseline to 12 weeks in pg/mL

Outcome measures

Measure	Blueberry Supplementation n=10 Participants All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Change in Brain-derived Neurotrophic Factor (BDNF) Baseline	1685.48 pg/mL Standard Error 480.43
Change in Brain-derived Neurotrophic Factor (BDNF) 12 weeks	1850.15 pg/mL Standard Error 436.63

Adverse Events

Blueberry Supplementation

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Blueberry Supplementation n=10 participants at risk All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Nervous system disorders altered mental status	10.0% 1/10 • Number of events 1 • 12 weeks

Other adverse events

Measure	Blueberry Supplementation n=10 participants at risk All participants will receive 18 grams lyophilized blueberry supplement mixed with water twice daily for 12 weeks. lyophilized blueberry supplement: lyophilized blueberry supplement bid
Gastrointestinal disorders constipation	20.0% 2/10 • Number of events 2 • 12 weeks
Gastrointestinal disorders diarrhea	10.0% 1/10 • Number of events 1 • 12 weeks
Nervous system disorders tremor/weakness	10.0% 1/10 • Number of events 1 • 12 weeks
Infections and infestations Covid infection	10.0% 1/10 • Number of events 1 • 12 weeks
Gastrointestinal disorders hematemesis	10.0% 1/10 • Number of events 1 • 12 weeks
Gastrointestinal disorders abdominal pain	10.0% 1/10 • Number of events 1 • 12 weeks

Additional Information

Dr. P. Murali Doraiswamy

Duke University Medical Center

Phone: 9196845933

Email: murali.doraiswamy@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place