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Tests treatment safety and results for Cognition
Official title A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Performance at Varying Dosages in Healthy Middle-aged and Older Adults With Self-reported Memory Problems
ClinicalTrials.gov ID: NCT07388043
What this study is testing
- What it's testing
- The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive performance at varying dosages in healthy middle-aged and older adults with self-reported memory problems. The main question it aims to answer is: What is the effect of AP-Brain at 1 g, 3 g, and 5 g on cognitive performance?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 79. Healthy volunteers may be eligible.
You may be able to join if
- Males and females 40-79 years of age, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy...
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable...
- Double-barrier method
- Intrauterine devices
You likely can't join if
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity...
- Self-reported color blindness/weakness as assessed by the QI
- Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
- Current employment that calls for overnight shiftwork as assessed by the QI
See the full eligibility criteria
Who can join
- Males and females 40-79 years of age, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been...
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant...
- 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
- Abstinence and agrees to use contraception if planning on becoming sexually active
- Individuals with self-reported memory problems as assessed by a combined score of ≥6 from the memory assessment questions provided at screening
- Absence of dementia or other significant cognitive impairment as assessed by MMSE-2 score of ≥24 at screening
- Agrees to avoid high sources of caffeine (e.g., supplements, tea, coffee, energy drinks), NSAIDs, and alcohol consumption for 24 hours prior to post-screening clinic visits
- Agrees to avoid first generation anti-allergy medication for 48 hours prior to post-screening clinic visits
- Agrees to avoid moderate-vigorous exercise 12 hours prior to post-screening clinic visits
- Agrees to avoid travel across two or more time zones two weeks prior to any study visit
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
- Willing and able to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history, laboratory results, and vital signs, as assessed by the QI
What rules you out
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, or intolerance to the investigational product or placebo ingredients
- Self-reported confirmation of any significant neuropsychological condition and/or cognitive impairment (e.g., attention-deficit/hyperactivity disorder, Schizophrenia, bipolar disorder, post-traumatic stress disorder...
- Self-reported color blindness/weakness as assessed by the QI
- Individuals who consume high caffeine daily or are addicted to caffeine at screening as assessed by the QI
- Current employment that calls for overnight shiftwork as assessed by the QI
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Current or history of significant diseases of the gastrointestinal tract or conditions that result in malabsorption, 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 (See Section 7.3.1)
- Type I diabetes
- Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an HbA1c of \<8.0% may be included after assessment 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
- History of or current diagnosis with kidney, gallbladder (e.g., gallstones, bile duct obstruction), and/or liver diseases (e.g., reduced bile salts, SIBO) as assessed by the QI on a case-by-case basis, with the...
- Self-reported 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
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma 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...
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of \>2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Current use of prescribed and/or OTC medications, supplements, and/or consumption of food/drinks that may impact the how well it works and/or safety of the investigational product (Sections 7.3.1 and 7.3.2)
- Current or previous use of cognitive training programs or therapies, as assessed by the QI
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are cognitively impaired and/or unable to give informed consent
- Any other condition or lifestyle factor, 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
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.