Trial Outcomes & Findings for Dementia Risk and Dynamic Response to Exercise (NCT NCT04009629)
NCT ID: NCT04009629
Last Updated: 2022-05-03
Results Overview
Cumulative cerebral blood flow measured by Arterial Spin Labeling MRI. The standard arterial spin labeling unit of measure is average milliliters per 100 grams of tissue per minute (mL/100g tissue/minute). For the present analysis, we summed perfusion over the entire acquisition period, 23.2 minutes, rather than averaging. Therefore the units are milliliters per 100 grams of tissue
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
~24 minutes
Results posted on
2022-05-03
Participant Flow
Participant milestones
| Measure |
APOE4 Carrier
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
38
|
|
Overall Study
COMPLETED
|
21
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
APOE4 Carrier
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Dementia Risk and Dynamic Response to Exercise
Baseline characteristics by cohort
| Measure |
APOE4 Carriers
n=23 Participants
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carriers
n=38 Participants
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
73.3 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
72.8 years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
38 participants
n=107 Participants
|
61 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: ~24 minutesCumulative cerebral blood flow measured by Arterial Spin Labeling MRI. The standard arterial spin labeling unit of measure is average milliliters per 100 grams of tissue per minute (mL/100g tissue/minute). For the present analysis, we summed perfusion over the entire acquisition period, 23.2 minutes, rather than averaging. Therefore the units are milliliters per 100 grams of tissue
Outcome measures
| Measure |
APOE4 Carrier
n=21 Participants
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
n=38 Participants
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Cerebral Blood Flow Area Under Curve
|
715 mL/100g tissue
Standard Deviation 105.0
|
751 mL/100g tissue
Standard Deviation 87.6
|
SECONDARY outcome
Timeframe: Pre-to-post intervention (~15 minutes)Population: Blood collection failed on three individuals in the APOE4 carrier group. Outcome could not be analyzed.
Change in circulating Insulin-like Growth Factor-1 from pre-to-post exercise
Outcome measures
| Measure |
APOE4 Carrier
n=20 Participants
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
n=38 Participants
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Insulin-like Growth Factor-1 Change
|
2.25 picograms per milliliter
Standard Deviation 22.8
|
5.7 picograms per milliliter
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: Pre-to-post intervention (~15 minutes)Population: Blood collection failed on three individuals in the APOE4 carrier group. Outcome could not be analyzed.
Change in circulating Vascular Endothelial Growth Factor from pre-to-post exercise
Outcome measures
| Measure |
APOE4 Carrier
n=20 Participants
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
n=38 Participants
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Vascular Endothelial Growth Factor Change
|
-1.01 picograms per milliliter
Standard Deviation 10.6
|
1.83 picograms per milliliter
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Pre-to-post intervention (~15 minutes)Population: Blood collection failed on three individuals in the APOE4 carrier group. Outcome could not be analyzed.
Change in circulating Brain Derived Neurotrophic Factor from pre-to-post exercise
Outcome measures
| Measure |
APOE4 Carrier
n=20 Participants
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
n=38 Participants
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Brain Derived Neurotrophic Factor Change
|
-219 picograms per milliliter
Standard Deviation 641
|
208 picograms per milliliter
Standard Deviation 706
|
Adverse Events
APOE4 Carrier
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
APOE4 Non-carrier
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APOE4 Carrier
n=23 participants at risk
Participants with 1 or 2 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
APOE4 Non-carrier
n=38 participants at risk
Participants with 0 copies of the APOE4 allele, the leading genetic risk factor for late-onset Alzheimer's dementia.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • 1 day
Adverse events were defined as any untoward or unfavorable medical occurrence in a human subject participant, including any abnormal sign, symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
0.00%
0/38 • 1 day
Adverse events were defined as any untoward or unfavorable medical occurrence in a human subject participant, including any abnormal sign, symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place