Protective factors for dementia in subjects aged 90 years and older

Phase 1

• Conditions: The protective factors of Alzheimer's disease in subjects aged 90 years and older; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-002635-15-NL
• Lead Sponsor: VU Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Age = 90 years Candidate is able to walk 400 meter independently (with or without walking aid) No significant visual or hearing impairment (as judged by clinician) Cognitively intact group: - MMSE = 27 points - Clinical Dementia Rating (CDR) = 0.0 points Cognitive impaired group: - MMSE: 20-28 points inclusively - CDR = 1 point(s) - Determination that this dysfunction is due to cognitive functional loss and not physical impairment, as judged by a neurologist or internist-geriatrician. There is an overlap in MMSE score but this has no effect on the contrast between the two groups. The two groups are based on dementia diagnosis and the MMSE score has no influence on this diagnosis. Someone with a MMSE of 27 can be both dement or cognitively healthy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Clinical diagnosis of severe AD Severe head trauma, with loss of consciousness Brain tumour (past, present) Schizophrenia, bipolar disorder, or recurrent psychotic disorders Stroke resulting in physical impairment Non-AD neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt­Jacob disease, primary progressive aphasia, Parkinson’s disease, diffuse Lewy body disease, frontotemporal dementia, primary vascular dementia) Epilepsy, currently using antiepileptic drugs (AEDs) Brain infections (e.g. herpes simplex encephalitis) Cancer with terminal life expectancy (life expectancy <12 months) Cancer chemotherapy or radiotherapy within the last 3 months Known B12 vitamin deficiency without treatment Uncontrolled diabetes mellitus (last measure HbA1c >80 mmol/mol) Known thyroid disease without treatment History of recreational drug use Alcohol consumption: >35 units per week (1 unit = 10ml of pure alcohol) Physical morbidity or illness which will not permit attendance at visit sessions Contraindication for MRI (e.g. metal implants, pacemaker etc.) Medications that may impair cognition, at the discretion of the investigator, e.g.: - Benzodiazepine with known effects on cognitive functioning - Lithium carbonate - Antipsychotics including atypical agents - Antidepressants with known effects on cognitive functioning - Parkinson’s disease medicines

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified