Clinical Trial: NCT05894954
Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | Alzheimer's Prevention and Reversal Project, Inc. |
| Information Provided By: | Alzheimer's Prevention and Reversal Project, Inc. |
| Last Update Posted: | 2026-02-18 |
Study Overview
Brief Summary
The goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage dementia. Precision medicine approach starts with the completion of many tests and then the study doctor uses the test results to carefully prepare a treatment plan that is best for the individual person to help treat many of the underlying causes of mild cognitive impairment or early-stage dementia.
The main question the study aims to answer is:
• Does the precision medicine approach improve memory (cognitive function) better than the current standard-of-care treatment in people with mild cognitive impairment or early-stage dementia during a 9-month treatment period? This is a randomized clinical trial which means that a group of people that meet the study requirements will be assigned at random or by chance (like toss of a coin) to receive either the precision medicine treatment or the current gold standard (standard-of-care). People assigned to the precision medicine group will receive precision medicine for 9-months while those assigned to the standard-of-care group will follow that approach for 9-months, followed by an opportunity to receive up to six months of precision medicine, if desired.
Participants will be asked to:
- Have their blood drawn for extensive lab testing and collect urine and stool samples as well
- Carefully follow instructions received from their study doctor and study team
- Make lifestyle changes as prescribed by the study doctor and study team based on your precision medicine program
- Take supplements and medications prescribed by the study doctor.
- Once officially in the study (after meeting study entry or screening requirements), participate in ten (10) monthly visits with the study doctor, and other members of the study team as scheduled.
- Complete cognitive tests at scheduled visits during the study
- Have a study partner with you during visits and to help support you on the program Researchers will compare test results between the two study groups to see if the precision medicine approach improves those tests results over the time of the study, resulting in the improvement of cognition over a 9-month treatment period.
Official Title
Conditions
Intervention / Treatment
- Dietary Supplement: Precision Medicine Approach
- Combination Product: Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises
- Behavioral: Standard-of-Care
- Behavioral: Lifestyle including diet, exercise, stress management
Other Study ID Numbers
- EVANTHEA-2023
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Alzheimer's Prevention and Reversal Project, Inc. |
| Information Provided By: | Alzheimer's Prevention and Reversal Project, Inc. |
| Last Update Posted: | 2026-02-18 |
Study Overview
Brief Summary
The goal of this clinical trial is to compare a precision medicine approach to the standard-of-care for people with mild cognitive impairment or early-stage dementia. Precision medicine approach starts with the completion of many tests and then the study doctor uses the test results to carefully prepare a treatment plan that is best for the individual person to help treat many of the underlying causes of mild cognitive impairment or early-stage dementia.
The main question the study aims to answer is:
• Does the precision medicine approach improve memory (cognitive function) better than the current standard-of-care treatment in people with mild cognitive impairment or early-stage dementia during a 9-month treatment period? This is a randomized clinical trial which means that a group of people that meet the study requirements will be assigned at random or by chance (like toss of a coin) to receive either the precision medicine treatment or the current gold standard (standard-of-care). People assigned to the precision medicine group will receive precision medicine for 9-months while those assigned to the standard-of-care group will follow that approach for 9-months, followed by an opportunity to receive up to six months of precision medicine, if desired.
Participants will be asked to:
- Have their blood drawn for extensive lab testing and collect urine and stool samples as well
- Carefully follow instructions received from their study doctor and study team
- Make lifestyle changes as prescribed by the study doctor and study team based on your precision medicine program
- Take supplements and medications prescribed by the study doctor.
- Once officially in the study (after meeting study entry or screening requirements), participate in ten (10) monthly visits with the study doctor, and other members of the study team as scheduled.
- Complete cognitive tests at scheduled visits during the study
- Have a study partner with you during visits and to help support you on the program Researchers will compare test results between the two study groups to see if the precision medicine approach improves those tests results over the time of the study, resulting in the improvement of cognition over a 9-month treatment period.
Official Title
Conditions
Intervention / Treatment
- Dietary Supplement: Precision Medicine Approach
- Combination Product: Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises
- Behavioral: Standard-of-Care
- Behavioral: Lifestyle including diet, exercise, stress management
Other Study ID Numbers
- EVANTHEA-2023