HealthyNCT04149639
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
A study testing NeuroQ in people with Healthy, run by LifeSeasons Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NeuroQ
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2019to 7 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- BMI between 18.5 and 32.5 kg/m2
Show all 14Show fewer
- 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
Who cannot join
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's (IP) active or inactive ingredients
- 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
- Participants with vitamin deficiencies affecting cognition:
- Magnesium
Show all 30Show fewer
- Cobalamin (Vitamin B12)
- Folate below the normal clinical ranges, as assessed by the QI
- Participants who test below the 24th percentile or above the 75th percentile in all domains in the NCI.
- Current use of prescribed medications listed in Section 8.3.1.
- Current use of over-the-counter medications, supplements, foods and/or drinks listed as concomitant medications.
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Type II diabetes. Treatment on a stable dose of medication may be considered by the QI on a case by case basis
- 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
- 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
- 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
- Individuals who are immune-compromised
- Verbal confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
- 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
- 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
- Current or history of any significant diseases of the gastrointestinal tract
- Verbal confirmation of blood/bleeding disorders
- Self-reported chronic use of cannabinoid products or currently taking medical cannabinoid products containing >0.3% tetrahydrocannabinol
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (>2 drinks per day or >10 standard drinks per week)
- Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
- Participation in other clinical research trials 30 days prior to screening
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
LifeSeasons Medical Center
Flower Mound, Texas, 75077
Kapoor Medical Center
Studio City, California, 91604
About this study
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
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.
- Conditions
- Healthy
- Being tested
- NeuroQ
- Keywords
- NeuroQ, Dr. Bredesen, PreCODE protocol, ReCODE method, cognitive decline, The End of Alzheimer's, cognitive support, cognitive health
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroQDietary supplement
Supplement includes phosphatidylserine, coffee fruit, curcumin, ginkgo, gotu kola, and propolis active ingredients inside a veggie capsule.
| Study group | Role | What they receive |
|---|---|---|
| NeuroQ | Experimental | Directions: take 2 capsules at the same time daily Receives: Dietary Supplement: NeuroQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90-135 days
Secondary outcomes (16)
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
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.
Measured: 90-135 days
Number of participants motivated to make lasting changes to their lifestyle at end-of-study.
Measured: 90-120 days
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.
Measured: 90-135 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start8 Nov 2019
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeSeasons Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- Jamie Langston, Study director, LifeSeasons Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149639
- Sponsor's protocol ID
- 19IPHL
- Status last verified
- Nov 2019
- First submitted
- 30 Oct 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04149639
- Acronym / sponsor ID
- 19IPHL
- Conditions
- Healthy
- Keywords
- NeuroQ, Dr. Bredesen, PreCODE protocol, ReCODE method, cognitive decline, The End of Alzheimer's, cognitive support, cognitive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- LifeSeasons Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label design
| Arm | Type | Receives |
|---|---|---|
| NeuroQ | Experimental | Dietary Supplement: NeuroQDirections: take 2 capsules at the same time daily |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females 45 years of age or older with one or more of the following risk factors for cognitive decline:
- BMI between 18.5 and 32.5 kg/m2
- 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:
Key exclusion criteria (30 listed)
- Women who are pregnant, breast feeding, or planning to become pregnant during the trial
- Allergy, sensitivity, or intolerance to the investigational product's (IP) active or inactive ingredients
- Self-reported confirmation of neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation. For e.g.:
- Participants with vitamin deficiencies affecting cognition:
- Participants who test below the 24th percentile or above the 75th percentile in all domains in the NCI.
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 |
|---|---|---|
| NeuroQSupplement includes phosphatidylserine, coffee fruit, curcumin, ginkgo, gotu kola, and propolis active ingredients inside a veggie capsule. | Dietary supplement | NeuroQ |
Primary outcome
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.
Time frame: 90-135 days
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.
16 secondary outcomes
Change in Neurocognitive Index (NCI) individual domains from screening to end-of study in participants who are fully compliant with supplementation and lifestyle modification
Time frame: 90-135 days
Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with supplementation only
Time frame: 90-135 days
Change in Neurocognitive Index (NCI) individual domains from screening to end-of-study in participants who are compliant with lifestyle modification only
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - composite memory from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - verbal memory from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - visual memory from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - psychomotor speed from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - reaction time from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - complex attention from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - cognitive flexibility from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - processing speed from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - executive function from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - simple attention from screening to end-of-study
Time frame: 90-135 days
Change in individual Central Nervous System-Vital Signs (CNS-VS) domain - motor speed from screening to end-of-study
Time frame: 90-135 days
Number of participants motivated to make lasting changes to their lifestyle at end-of-study.
Time frame: 90-120 days
Change in Mini Mental State Exam Version 2 (MMSE-2) score from screening to end-of study.
Time frame: 90-135 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Jamie Langston study director
LifeSeasons Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroQ in people with Healthy, run by LifeSeasons Inc. 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 14 inclusion and 30 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 2 Mar 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cognition as assessed by change in Neurocognitive Index (NCI) score from CNS-Vital Signs (CNS-VS) panel from screening to end-of-study. (time frame: 90-135 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.