← Back to Search

Diet

Therapeutic Diets for Alzheimer's Disease (TDAD Trial)

Q: How many participants are currently involved in this research?

Affirmative. According to the information preserved on clinicaltrials.gov, this research is still actively recruiting individuals for participation. The trial was initially posted on October 29th 2019 and last amended on October 31st 2022; 80 volunteers are being sought at a single site.

Q: Does the enrollment criteria for this research encompass individuals under 35 years of age?

In order to be considered for this trial, applicants must fall between the age range of 50 and 90.

Q: What criteria must a participant meet to qualify for this clinical research project?

This research endeavour is in need of 80 patients who are between 50 to 90 years old and have been diagnosed with alzheimer disease. In addition, participants must possess a CDR global score of 0.5 or 1, consent from an appropriate study partner, and not have modified their medication within the past 30 days.

Q: Are there any open recruitment spots for this trial?

Affirmative. According to information presented on clinicaltrials.gov, this medical study is actively recruiting participants as of October 31st 2022 - the last time it was updated from its original posting date of October 29th 2019. 80 patients are needed for enrollment at a single site.

N/A

Recruiting

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 to 90

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 weeks, 12 weeks

Awards & highlights

TDAD Trial Summary

This trial will study how two different diets affect thinking and memory in people with Alzheimer's disease.

Who is the study for?

This trial is for individuals aged 50 to 90 with Alzheimer's Disease, as diagnosed by McKhann et al. criteria. Participants must speak English, have a stable medication regimen for the past month, and score 0.5 or 1 on the CDR scale. They need a study partner and cannot be in nursing care or another trial, nor can they have renal stones, insulin-requiring diabetes, recent cancer treatments or cardiac events.Check my eligibility

What is being tested?

The study aims to compare how two diets—the Ketogenic Diet and Therapeutic Lifestyles Changes Diet—affect cognitive function in Alzheimer's patients. Researchers will observe changes in cognition to determine any potential benefits of these dietary interventions.See study design

What are the potential side effects?

Potential side effects from these diets may include digestive issues like constipation or diarrhea due to changes in food intake. The ketogenic diet might also cause low blood sugar levels, fatigue during initial adjustment periods, and possibly an increased risk of kidney stones.

TDAD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 50 and 90 years old.

TDAD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 weeks, 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 weeks, 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Clinical Dementia Rating (CDR)

Change in cognitive performance by Stroop test

Change in cognitive performance on the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADASCog11)

+2 more

Secondary outcome measures

Change in blood platelet mitochondrial function

Change in cerebral concentration of N-Acetylaspartate (NAA)

Change in self-reported symptoms by study partner

Other outcome measures

Change in blood ketone levels induced by ketogenic diet

Dietary intake characterization prior to and after ketogenic diet initiation

Proportion of days positive for urinary ketone production

TDAD Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ketogenic DietExperimental Treatment1 Intervention

Study partners will be instructed to assist participants in adherence to a 1:1 ketogenic diet (approximately 70% fat, <10% carbohydrate, and 20% protein as energy). The diet will encourage ≥4 servings of non-starchy vegetables and 1/2 cup of berries daily. Participants will be provided an emulsified medium chain triglyceride supplement with a target intake of 1-2 tablespoons per day and micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus. After the 3-month ketogenic diet, participants will complete a 1-month washout period in which they halt adherence to the ketogenic diet and resume their normal diet.

Group II: Therapeutic Lifestyles Changes DietActive Control1 Intervention

Study partners will be instructed to assist participants in adherence to the Therapeutic Lifestyles Changes diet. The diet consists of 20-35% fat, 50-60% carbohydrate, and ~15% protein as energy. Fat intake will comprise <7% saturated fat, ≤20% monounsaturated fat, and ≤10% polyunsaturated fat as total energy. Cholesterol consumption will be ≤200mg per day. Participants are encouraged to eat ≥2 servings of fruit and ≥5 servings of vegetables per day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketogenic Diet

2016

Completed Phase 2

~460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,672 Previous Clinical Trials

28,018,583 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

462 Previous Clinical Trials

169,127 Total Patients Enrolled

Media Library

Ketogenic Diet (Diet) Clinical Trial Eligibility Overview. Trial Name: NCT03860792 — N/A

Alzheimer's Disease Research Study Groups: Ketogenic Diet, Therapeutic Lifestyles Changes Diet

Alzheimer's Disease Clinical Trial 2023: Ketogenic Diet Highlights & Side Effects. Trial Name: NCT03860792 — N/A

Ketogenic Diet (Diet) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03860792 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research?

"Affirmative. According to the information preserved on clinicaltrials.gov, this research is still actively recruiting individuals for participation. The trial was initially posted on October 29th 2019 and last amended on October 31st 2022; 80 volunteers are being sought at a single site."

Answered by AI

Does the enrollment criteria for this research encompass individuals under 35 years of age?

"In order to be considered for this trial, applicants must fall between the age range of 50 and 90."

Answered by AI

What criteria must a participant meet to qualify for this clinical research project?

"This research endeavour is in need of 80 patients who are between 50 to 90 years old and have been diagnosed with alzheimer disease. In addition, participants must possess a CDR global score of 0.5 or 1, consent from an appropriate study partner, and not have modified their medication within the past 30 days."

Answered by AI

Are there any open recruitment spots for this trial?

"Affirmative. According to information presented on clinicaltrials.gov, this medical study is actively recruiting participants as of October 31st 2022 - the last time it was updated from its original posting date of October 29th 2019. 80 patients are needed for enrollment at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapeutic Diets in Alzheimer's Disease

Russell Swerdlow 2019. "Therapeutic Diets in Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03860792.

All > Alzheimer Disease > Alzheimers Disease