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NCT05894954 · ClinicalTrials.gov registry record · Phase 3
Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
A Phase 3 study of Mild Cognitive Impairment and Dementia, Mild, sponsored by Alzheimer's Prevention and Reversal Project.
- Completed
- Registry status
- Phase 3
- Development phase
- 73
- Enrollment target
- 6
- Study locations
NCT05894954 is a Phase 3 study of Mild Cognitive Impairment and Dementia, Mild that has completed, run by Alzheimer's Prevention and Reversal Project. The registered enrollment target is 73 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 4 states.
The verdict
NCT05894954, a Phase 3 study of Mild Cognitive Impairment and Dementia, Mild, has completed, sponsored by Alzheimer's Prevention and Reversal Project.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 73 participants
- Enrollment target
- 6
- Study locations
Study 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 t
Conditions Studied
Interventions
- 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
Study Locations (6)
California
- True Health Center for Functional Medicine - Folsom
- Ann Hathaway, MD - San Rafael
- Bay Area Wellness - Walnut Creek
Florida
- Rezilir Health - Hollywood
Ohio
- Kemper Cognitive Wellness - Rocky River
Tennessee
- MaxWell Clinic, PLC - Brentwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2023-07-31 |
| Est. Completion | 2026-02-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05894954
The ClinicalTrials.gov registry entry for NCT05894954 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (94% lower). The listed sponsor is Alzheimer's Prevention and Reversal Project, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 4 interventions - of which Precision Medicine Approach is the first listed.
NCT05894954 reports 6 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT05894954 about?
NCT05894954 is a clinical study titled "Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment". 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 pre...
What is the current status of trial NCT05894954?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 73 participants. The study started on 2023-07-31. Estimated completion is 2026-02-09.
What conditions does trial NCT05894954 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Dementia, Mild.
What interventions are being tested in trial NCT05894954?
The interventions under investigation include: Precision Medicine Approach (DIETARY_SUPPLEMENT), Hormones and Medications tailored to lab tests, combined with devices that support stress management and brain exercises (COMBINATION_PRODUCT), Standard-of-Care (BEHAVIORAL), Lifestyle including diet, exercise, stress management (BEHAVIORAL).
Who is sponsoring clinical trial NCT05894954?
This trial is sponsored by Alzheimer's Prevention and Reversal Project, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05894954 being conducted?
This trial has 6 study locations across California, Florida, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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