Study to identify early signs of Alzheimer's disease in healthy elderly people

Not Applicable

Completed

• Conditions: Healthy subjects with Alzheimer biomarkers/pathology; Nervous System Diseases

• Registration Number: ISRCTN79036545
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34274005/ (added 19/07/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35922871/ (added 04/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-11-13
• Study Start: 2020-04-20
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Aged 65 and older (inclusive)
2. Willing and able to perform the cognitive tests, as evidenced by performance on the training session of the cognitive tests
3. Willing and able to give written informed consent and to comply with the study procedures

Exclusion Criteria

1. Legal incapacity or inability to understand or comply with the requirements of the study
2. Evidence of cognitive deterioration, as indicated by a diagnosis of a cognitive disorder (including but not limited to MCI, Alzheimer’s disease, Lewy Body Dementia, Fronto-temporal Dementia)
3. History or symptoms of significant psychiatric disease in the past 3 years (including but not limited to clinical depression, schizophrenia);
4. A Mini Mental State Examination (MMSE) score of =24
5. A Geriatric Depression Scale – 15 (GDS) score of =6
6. Presence of drug abuse, or positive urine drug screen (UDS) at screening or occasion
7. Presence of severe alcohol abuse (daily alcohol consumption exceeding 2 standard drinks per day on average for females or exceeding 3 standard drinks per day on average for males (1 standard drink = 10 grams of alcohol)), or a positive breath alcohol test at screening or occasion
8. Any contradictions for a lumbar puncture as judged by the principal investigator
9. Any other reason that it is not safe or ethical to allow a subject to participate in the study in the opinion of the investigator

Study & Design

• Study Type: Observational
• Study Design: Not specified