A Study Investigating the Effectiveness of a LifeSeasons NeuroQ Supplement With Lifestyle Changes to Improve Cognitive Function in Healthy Adults Who Have One or More Risk Factors for Cognitive Decline

Healthy Clinical Trial

Official title:

An Open-label Study to Investigate the Effectiveness of a LifeSeasons NeuroQ Supplement in Addition to Four Bredesen Recommended Lifestyle Changes to Improve Cognitive Function in Healthy Adults Who Have One or More Risk Factors for Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149639
• Other study ID #: 19IPHL
• Status: Completed
• Phase: N/A
• Start date: November 8, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: November 2019
• Source: LifeSeasons Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the efficacy of a NeuroQ supplement designed by Dr. Bredesen to complement his Lifestyle modification protocol. Eligible participants will be expected to consume the NeuroQ supplement and are recommended to make lifestyle changes based on Dr. Bredesen's protocol. Forty participants are expected to enroll into the study, completing study assessments at check in visits days 30 and 60, and at the end of study visit on day 90. A brief follow up phone call will be conducted approximately 30 days after study completion to ask participants if they have continued using the lifestyle changes and if they have purchased and continued to consume the NeuroQ supplement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 7, 2020
• Est. primary completion date: July 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

1. Males and females 45 years of age or older with one or more of the following risk factors for cognitive decline:

• Self-reported genetic risk factor of Alzheimer's Disease or dementia as confirmed by Apolipoprotein 4 genetic testing

• Self-reported family history of Alzheimer's Disease or dementia in a first-degree relative

• Self-reported lifestyle risk factor: sedentary lifestyle; poor dietary habits (e.g. insufficient consumption of fruits and vegetables for necessary nutrients); poor social support network (e.g. majority of evenings and weekends are spent in isolation); poor stress management skills (e.g. binge eating habits or performing harmful activities during periods of stress); poor sleep habits; metabolic syndrome

• Exception: Individuals 60 years of age or older may be enrolled without any of the above risk factors.

2. BMI between 18.5 and 32.5 kg/m2

3. Female participants are not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening

or,

Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)

• Double-barrier method

• Intrauterine devices

• Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)

• Vasectomy of partner at least 6 months prior to screening 4. Self-reported as non-smoker or user of any nicotine-containing products 5. Absence of dementia or other significant cognitive impairment as assessed by Mini Mental State Exam-2 Standard Version (MMSE-2) score =24 6. Participants who test between the 24-75th percentile in the in one or more domains in the NCI 7. Low frequency of depressed mood as assessed by PHQ-9 score of 4 or less 8. Agree to avoid caffeine consumption 24 hours prior to in-clinic visits 9. Agree to avoid alcohol consumption 24 hours prior to in-clinic visits 10. Healthy as determined by medical history and laboratory results as assessed by QI

Exclusion Criteria:

1. Women who are pregnant, breast feeding, or planning to become pregnant during the trial

2. Allergy, sensitivity, or intolerance to the investigational product's (IP) active or inactive ingredients

3. Self-reported confirmation of neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation. For e.g.:

• Schizophrenia, bipolar disorder, post-traumatic stress disorder, brain injury, neurodegenerative disease, infections, insomnia

4. Participants with vitamin deficiencies affecting cognition:

• Magnesium

• Cobalamin (Vitamin B12)

• Folate below the normal clinical ranges, as assessed by the QI

5. Participants who test below the 24th percentile or above the 75th percentile in all domains in the NCI.

6. Current use of prescribed medications listed in Section 8.3.1.

7. Current use of over-the-counter medications, supplements, foods and/or drinks listed as concomitant medications.

8. Unstable metabolic disease or chronic diseases as assessed by the QI

9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI

10. Type II diabetes. Treatment on a stable dose of medication may be considered by the QI on a case by case basis

11. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis

12. Major surgery in the past 3 months or individuals who have planned surgery during the course of the trial. Participants with minor surgery will be considered on a case-by-case basis by the QI

13. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable

14. Individuals who are immune-compromised

15. Verbal confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis

16. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom free for 6 months

17. Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI

18. Current or history of any significant diseases of the gastrointestinal tract

19. Verbal confirmation of blood/bleeding disorders

20. Self-reported chronic use of cannabinoid products or currently taking medical cannabinoid products containing >0.3% tetrahydrocannabinol

21. Alcohol or drug abuse within the last 12 months

22. High alcohol intake (>2 drinks per day or >10 standard drinks per week)

23. Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit

24. Participation in other clinical research trials 30 days prior to screening

25. Individuals who are unable to give informed consent

26. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy

Intervention

Dietary Supplement:
• NeuroQ
Supplement includes phosphatidylserine, coffee fruit, curcumin, ginkgo, gotu kola, and propolis active ingredients inside a veggie capsule.

Locations

Country	Name	City	State
United States	LifeSeasons Medical Center	Flower Mound	Texas
United States	Kapoor Medical Center	Studio City	California

Sponsors (2)

Lead Sponsor	Collaborator
LifeSeasons Inc.	KGK Science Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of pre-emergent and post-emergent adverse events following 30-day, supplementation.		30 days
Other	Incidence of pre-emergent and post-emergent adverse events following 60-day, supplementation.		60 days
Other	Incidence of pre-emergent and post-emergent adverse events following 90-day, supplementation.		90 days
Other	Change in systolic blood pressure following 30-day supplementation		30 days
Other	Change in systolic blood pressure following 60-day supplementation		60 days
Other	Change in systolic blood pressure following 90-day supplementation		90 days
Other	Change in diastolic blood pressure following 30-day supplementation		30 days
Other	Change in diastolic blood pressure following 60-day supplementation		60 days
Other	Change in diastolic blood pressure following 90-day supplementation		90 days
Other	Change in heart rate following 30-day supplementation		30 days
Other	Change in heart rate following 60-day supplementation		60 days
Other	Change in heart rate following 90-day supplementation		90 days
Other	Change in CMP following 90-day supplementation		90 days
Other	Change in complete blood count following 90-day supplementation		90 days
Other	Change in neutrophil levels in the blood following 90-day supplementation	Units: XE9/L	90 days
Other	Change in lymphocyte blood levels following 90-day supplementation	Units: XE9/L	90 days
Other	Change in monocyte blood levels following 90-day supplementation	Units: XE9/L	90 days
Other	Change in eosinophil blood levels following 90-day supplementation	Units: XE9/L	90 days
Other	Change in basophil blood levels following 90-day supplementation	Units: XE9/L	90 days
Other	Change in red blood cell (RBC) count following 90-day supplementation		90 days
Other	Change in hemoglobin levels in the blood following 90-day supplementation	Units: g/L	90 days
Other	Change in hematocrit levels in the blood following 90-day supplementation	Units: L/L	90 days
Other	Change in platelet count following 90-day supplementation		90 days
Other	Change in mean corpuscular volume (MCV) following 90-day supplementation		90 days
Other	Change in mean corpuscular hemoglobin (MCH) following 90-day supplementation	Units: pg	90 days
Other	Change in mean corpuscular hemoglobin concentration (MCHC) following 90-day supplementation		90 days
Other	Change in red cell distribution width (RDW) following 90-day supplementation		90 days
Other	Difference in brain activity as measured by quantitative electroencephalography (qEEG) from baseline to end-of-study in 10 participants.	Alpha, Beta, Delta, and Theta bandwidths will be analyzed using the eVox system.	90 days
Primary	Change in cognition as assessed by change in Neurocognitive Index (NCI) score from CNS-Vital Signs (CNS-VS) panel from screening to end-of-study.	The Neurocognitive index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in Neurocognitive Index (NCI) individual domains from screening to end-of study in participants who are fully compliant with supplementation and lifestyle modification	The Neurocognitive index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with supplementation only	The Neurocognitive index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with lifestyle modification only	The Neurocognitive index is an average score derived from the domain scores or a general assessment of the overall neurocognitive status of the participant. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - composite memory from screening to end-of-study	The composite memory domain measures how well subject can recognize, remember, and retrieve words and geometric figures. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - verbal memory from screening to end-of-study	The verbal memory domain measures how well subject can recognize, remember, and retrieve words. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - visual memory from screening to end-of-study	The visual memory domain measures how well subject can recognize, remember and retrieve geometric figures. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - psychomotor speed from screening to end-of-study	The psychomotor speed domain measures how well a subject perceives, attends, responds to visual-perceptual information, and performs motor speed and fine motor coordination. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - reaction time from screening to end-of-study	The reaction time domain measures how quickly the subject can react, in milliseconds, to a simple and increasingly complex direction set. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - complex attention from screening to end-of-study	The complex attention domain measures the ability to track and respond to a variety of stimuli over lengthy periods of time and/or perform mental tasks requiring vigilance quickly and accurately. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - cognitive flexibility from screening to end-of-study	The cognitive flexibility domain measures how well subject is able to adapt to rapidly changing and increasingly complex set of directions and/or to manipulate the information. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - processing speed from screening to end-of-study	The processing speed domain measures how well a subject recognizes and processes information i.e., perceiving, attending/responding to incoming information, motor speed, fine motor coordination, and visual-perceptual ability. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - executive function from screening to end-of-study	The executive function domain measures how well a subject recognizes rules, categories, and manages or navigates rapid decision making. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - simple attention from screening to end-of-study	The simple attention domain measures the participants ability to track and respond to a single defined stimulus over lengthy periods of time while performing vigilance and response inhibition quickly and accurately. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - motor speed from screening to end-of-study	The motor speed domain measures the participants ability to perform movements to produce and satisfy an intention towards a manual action and goal. The scores range from less than 70 (very low) to above 110 (above average). A higher score means higher neurocognitive function and higher capacity.	90-135 days
Secondary	Number of participants motivated to make lasting changes to their lifestyle at end-of-study.		90-120 days
Secondary	Change in Mini Mental State Exam Version 2 (MMSE-2) score from screening to end-of study.	The Mini Mental State Exam Version 2 is an assessment of the level of consciousness. It is a series of 30 questions scored either 0 (incorrect) or 1 (correct). The range of scores is 0 to 30. A higher value means the participant answered more questions correctly.	90-135 days