Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00403507
Other study ID # Kelly Garrett
Secondary ID
Status Completed
Phase Phase 2
First received November 21, 2006
Last updated May 9, 2011
Start date October 2006
Est. completion date October 2009

Study information

Verified date November 2006
Source Intermountain Health Care, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities (e.g., husband, wife, adult child, or caregiver).


Description:

Currently, there is no cure for the memory loss associated with Alzheimer's disease, though some medications can help it from getting worse. The research study will help to answer the question if participation in an exercise program helps memory loss from getting worse, and if it improves daily functioning and attitudes of those with probable Alzheimer's disease. It will involve participation of both the person with memory loss and someone who knows their daily activities.

The research study is a randomized-control trial: some participants will be picked to participate in the exercise program, while others will not. Their memory, thinking abilities, activities, and attitudes will be measured at baseline and follow-up assessment 5-6 months later. Participants are in good health, and are treated with a cholinesterase inhibitor for memory loss (standard treatment).


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 65 Years to 89 Years
Eligibility Inclusion Criteria:

- Age is 65 through 89 years old.

- Completed more than an 8th grade education.

- Native English speaker.

- Diagnosis of probable Alzheimer's disease by a primary care physician or specialty clinic.

- Taking a cholinesterase inhibitor at a therapeutic dose for at least two weeks prior to admission to study (following minimum titration of four weeks), but no other prescribed medication for cognitive functioning (e.g., memantine/Namenda).

- May have one unstable physical illness that is being treated or a few controlled physical illnesses, is on few medications, and appears no more than mildly ill.

- Treated stable hypertension & hyperlipidemia are permissible, but resting blood pressure must be <170/100 mm Hg.

- Normal TSH & Vitamin B12 levels, as confirmed by laboratory data within 3 years.

- Able to participate a three-day/week physical activity program (No orthopedic, neurologic, or behavioral limitations that may preclude exercise training) for up to 6 months.

- Patient has a knowledgeable informant who can report the day-to-day activities of participant (e.g., spouse, adult child, paid caregiver).

- Able to give assent/consent to research study.

Exclusion Criteria:

- History of learning or developmental disability.

- Treatment with hormone replacement therapy during the last year.

- History of psychiatric condition (including depression).

- Evidence of serious cardiac condition or significant small vessel disease (e.g., heart bypass surgery, angina, arrhythmia, dyspnea, insulin-dependent diabetes with neuropathy, confluent white matter alterations on structural MRI or CT scan).

- History of neurologic condition (e.g., large vessel stroke, seizures, Parkinsonism).

- History of heavy metals exposure.

- History of sleep disturbance (e.g., treated apnea, insomnia).

- History of brain injury (including concussion of >10 minutes).

- History of delirium (change in mental status due to medications) for the past year.

- No pharmaceutical treatment for mood currently, or history of longstanding depression.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Participation in a monitored exercise program
No contact with control group during 20 weeks.
Personalized aerobic and strength training.
Three-days per week for 20 weeks at hospital gym under supervision of exercise specialist.

Locations

Country Name City State
United States LDS Hospital Salt Lake City Utah

Sponsors (2)

Lead Sponsor Collaborator
Intermountain Health Care, Inc. Deseret Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary For the intervention group: Change in cognitive performance relative to baseline baseline & 20 week follow-up No
Primary Group differences in cognitive performance following intervention and relative to wait-list control group baseline & 20 week follow-up No
Primary For the intervention group: Change in attitudes, including self-report of well-being and cognitive abilities relative to baseline baseline & 20 week follow-up No
Primary Group differences in attitudes, including self-report of well-being, following intervention and relative to wait-list control group baseline & 20 week follow-up No
Secondary For the intervention group: Change in knowledgeable informant's ratings of function, behavior, and attitudes baseline & 20 week follow-up No
Secondary Group differences in knowledgeable informant's ratings of function, behavior, and attitudes following intervention and relative to wait-list control group baseline & 20 week follow-up No
See also
  Status Clinical Trial Phase
Completed NCT04079803 - PTI-125 for Mild-to-moderate Alzheimer's Disease Patients Phase 2
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT04520698 - Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease N/A
Active, not recruiting NCT04606420 - Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease N/A
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Terminated NCT03672474 - REGEnLIFE RGn530 - Feasibility Pilot N/A
Completed NCT03430648 - Is Tau Protein Linked to Mobility Function?
Recruiting NCT04949750 - Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease N/A
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Recruiting NCT05288842 - Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
Recruiting NCT05557409 - A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation Phase 3
Completed NCT06194552 - A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 Phase 1
Completed NCT03239561 - Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants Early Phase 1
Completed NCT03184467 - Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients Phase 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Terminated NCT03487380 - Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT05328115 - A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease Phase 1
Completed NCT05562583 - SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support N/A