Indexing hint: Randomized controlled trial · 2013
Exenatide and the treatment of patients with Parkinson's disease.
Aviles-Olmos et al. 2013The Journal of clinical investigationcited by 440
PMID 23728174PMC3668846DOI 10.1172/jci68295PUB-23728174
Trial · Interventional
Status unknownPhase 3Registry dataShort name DRINN
Italy
1 trial
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The overall objective of the study is to assess the potential effects of the long-acting GLP-1 analogue exenatide in preventing/slowing the progression of cognitive dysfunction and related biomarkers in dysglycemic/prediabetic patients with mild cognitive impairment (MCI).
Experimental
exenatide
long-acting exenatide 2 mg subcutaneously once-weekly
Placebo comparator
placebo
no drug assigned
Outcomes the sponsor listed as primary.
Improvement of ADAS-cog Alzheimer's Disease Assessment Scale defined by ADAS-cog score at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the ADAS-Cog score compared to baseline in the 2 arms.
Improvement of Mini Mental State Evaluation test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the Mini Mental State Evaluation (MMSE) score compared to baseline in the 2 arms.
Improvement of Mini Mental State Evaluation quality test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the MMSE quality test score compared to baseline in the 2 arms.
Improvement of Phonemic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the Phonemic verbal fluency test score compared to baseline in the 2 arms.
Improvement of Semantic verbal fluency test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the Semantic verbal fluency test score compared to baseline in the 2 arms.
Improvement of Geriatric Depression Scale (GDS) test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the GDS test score compared to baseline in the 2 arms.
Improvement of Clinical Dementia Rating Scale (CDR) test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the CDR test score compared to baseline in the 2 arms.
Improvement of Neuropsychiatric Inventory (NPI) test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the NPI test score compared to baseline in the 2 arms.
Improvement of Activities of Daily Living (ADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the ADL test score compared to baseline in the 2 arms.
Improvement of Instrumental Activities of Daily Living (IADL) test at 16 (V2) and at 32 weeks (V3) compared to baseline
Time frame · 16 and 32 weeks
Absolute difference in the IADL test score compared to baseline in the 2 arms.
changes in structural and functional connectivity of neural networks as assessed by functional MRI (fMRI) at 16 (V2) and at 32 weeks (V3)
Time frame · 16 and 32 weeks
Before and after treatment voxel-wise brain maps will be statistically compared using Statistical Parametric Mapping, by a multivariate 2 x 2 ANOVA (experimental treatment /placebo x time pre/post) in order to observe changes in structural and functional connectivity of neural networks in relation to treatment
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2013
Aviles-Olmos et al. 2013The Journal of clinical investigationcited by 440
PMID 23728174PMC3668846DOI 10.1172/jci68295PUB-23728174
1 study on this page
Indexing hint: Animal study · 2014
McClean et al. 2014Neuropharmacologycited by 297
PMID 23973293DOI 10.1016/j.neuropharm.2013.08.005PUB-23973293
Who could join, as posted.
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